MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG STRYKERFLOW ELECTROCAUTERY PROBE J TIP 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070442
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
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 while the device was being pulled out of the patient into the sheath, it burnt the sheath.Therefore, there was a thermal event.
Additional Manufacturer Narrative
Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: burnt sheath probable root cause: 1.Generator power malfunction 2.Material/design error 3.Conductive irrigant used 4.Manufacturing / assembly error 5.User error the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that while the device was being pulled out of the patient into the sheath, it burnt the sheath.Therefore, there was a thermal event.

• Brand Name: PKG STRYKERFLOW ELECTROCAUTERY PROBE J TIP 5MM
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23187042
• Report Number: 0002936485-2025-00815
• Device Sequence Number: 21330124
• Product Code: GCJ
• UDI-Device Identifier: 07613327051889
• UDI-Public: 07613327051889
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 0250070442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 43 YR
• Patient Sex: Male