MAUDE Adverse Event Report: Stryker Endoscopy-San Jose SHEATH STRYKEPROBE; electrosurgical, cutting & coagulation & accessories

Catalog Number	0250070460
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the outer sheaths that look like it had some arcing and looked burnt during the case.They were looking at the l hooks, and it seems like the yellow insulation does not go all the way up to the hub.This happened during a case but no patient harm happened.
Event or Problem Description
It was reported that the outer sheaths that look like it had some arcing and looked burnt during the case.They were looking at the l hooks, and it seems like the yellow insulation does not go all the way up to the hub.This happened during a case but no patient harm happened.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, but the device has not been 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: arcing probable root cause: 1.Generator power malfunction 2.Material/design error 3.Conductive irrigant used 4.User error the reported failure mode will be monitored for future reoccurrence.

• Brand Name: SHEATH STRYKEPROBE
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25487283
• Report Number: 0002936485-2026-00378
• Device Sequence Number: 15935276
• Product Code: GEI
• UDI-Device Identifier: 07613327051971
• UDI-Public: 07613327051971
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K963765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 0250070460
• Device Lot Number: 080422-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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 Sex: Unknown