MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 90-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0279351100
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the patient was burned.
Event or Problem Description
It was reported that the patient was burned.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: burn to the user probable root cause: heat can result from insufficient suction which can result from: * inadequate hospital suction, leak, bad connection to hospital suction line, * clogging caused by suction path blockage, lower electrode mass due to variation in electrode thickness or opening cut.Use error.Lot number is unknown; therefore, manufacture date can not be confirmed.

• Brand Name: RF 2 PROBES, 90-S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11783188
• Report Number: 0002936485-2021-00241
• Device Sequence Number: 13683533
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0279351100
• Device Catalogue Number: 0279351100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other