MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RF 2 PROBES, 50-S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	0279351250
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the patient was burned.
Additional Manufacturer Narrative
Alleged failure: 50s rf wand burned the patients skin while it was being activated inside the joint the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be activation of the probe during insertion or removal from the joint space, inadequate suction causing hot saline to leak from the joint space, fluid irrigation.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient was burned.

• Brand Name: RF 2 PROBES, 50-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: 10414185
• Report Number: 0002936485-2020-00342
• Device Sequence Number: 16811782
• Product Code: GEI
• UDI-Device Identifier: 07613327056983
• UDI-Public: 07613327056983
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 0279351250
• Device Catalogue Number: 0279351250
• Device Lot Number: 19294AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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