MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250040112
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient suffered minor burn due to arcing.There was no medical intervention.
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.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: arcing causing patient burn probable root cause: heat conducted by device use error insulation damage or inadequate insulation from manufacturing/ servicing lot number is unknown; therefore, manufacture date can not be confirmed.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient suffered minor burn due to arcing.There was no medical intervention.

• Brand Name: PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15839524
• Report Number: 0002936485-2022-00694
• Device Sequence Number: 12191801
• Product Code: GCJ
• UDI-Device Identifier: 37613327061346
• UDI-Public: 37613327061346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• 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): 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0250040112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown