Video Processor May Cause Thermal Injury During Endoscopic Procedures
Pentax Medical Video Processor Model EPK-i8020c may overheat during endoscopic procedures, causing the light guide tip to become hot and risk thermal injury to patient tissues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a documented risk of thermal injury to patients, but no hospitalizations or confirmed patient injuries have been reported. It meets the criteria for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Pentax Medical Video Processor Model EPK-i8020c is being recalled due to a thermal hazard during endoscopic procedures. When used in combination with i20c series video endoscopes, the device can produce image quality issues (reddish or dark images) and generate smoke-like steam, indicating overheating of the light guide at the endoscope tip.
The recalled video processor may cause the light guide to become excessively hot during and immediately after use. Contact with the hot light guide can result in thermal injury to a patient's mucous membranes.
144 units of this device have been distributed across multiple US states including Arizona, California, DC, Florida, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania, Texas, and Washington. Healthcare facilities using this device model should immediately cease use of the recalled units pending a replacement or corrective action from the manufacturer.
Patients who underwent endoscopic procedures with this device and experienced burns or tissue injury should contact their healthcare provider.
The recalled product
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Manufacturer
- Pentax of America Inc
- Hazard
- thermal-injury
- overheating
- image-quality
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: EPK-i8020c
- UDI-DI: 04961333247974
- Serial Numbers: B0023Z1657
- D0023Z0245
- D0023Z0206
- D0023Z0125
- D0023Z0123
- D0023Z0119
- D0023Z0118
- D0023Z0117
- D0023Z0114
- D0023Z0112
- D0023Z0109
- D0023Z0108
- D0023Z0011
- C0023Z0087
- C0023Z0085
- C0023Z0074
- C0023Z0072
- C0023Z0021
Distribution
Distributed in 20 states:
- AZ
- CA
- DC
- FL
- IA
- ID
- IL
- KS
- MA
- MD
- MI
- MO
- NC
- NJ
- NM
- NY
- OK
- PA
- TX
- WA
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