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

Model Number	0279351100
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
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 there was a patient burn.
Event or Problem Description
It was reported that there was a patient burn.
Additional Manufacturer Narrative
The device manufacturer date is not known.Alleged failure: patient burned on non-operative arm, facility thinks may have come from radiofrequency wand.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Per visual and functional testing no defect and/or manufacturing-related condition was observed that could have contributed to the reported event.The probable root cause/s could be hot saline leaking (due to improper connection between the suction probe and the suction source), the probe suction tubing unintentionally touching the patient's skin and was maintained for a substantial amount of time.Other possibilities were activation of the probe during insertion or removal from the joint space, inadequate suction causing hot saline to leak from the joint space, and fluid irrigation.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16199930
• Report Number: 0002936485-2023-00043
• Device Sequence Number: 14859644
• Product Code: GEI
• UDI-Device Identifier: 07613327056952
• UDI-Public: 07613327056952
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K160050
• 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): 03/14/2023

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
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown