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

Catalog Number 0250040112

Device Problems Overheating of Device (1437); Arcing (2583)

Patient Problems Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

It was reported that the patient suffered minor burn due to arcing.There was no medical intervention.

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.

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 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
• Type of Device: 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
• MDR Text Key: 304192517
• Report Number: 0002936485-2022-00694
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 37613327061346
• UDI-Public: 37613327061346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250040112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1