MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, WORKING ELEMENT, PASSIVE; HYSTEROSCOPE AND ACCESSORIES

Catalog Number	0502880401
Medical Device Problem Codes	Material Fragmentation (1261); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 the loop electrode would not lock into working element of the resectoscope.The surgeon and staff had to find alternate solutions to attempt the completion of the case prior to officially cancelling the procedure.Anesthesia was administered to the patient and there was no incision made.
Additional Manufacturer Narrative
Alleged failure: it was reported by the sales rep (b)(6) loop electrode would not lock into working element of the resectoscope salesforce case number (b)(4).Anesthesia was administered to the patient prior to the cancellation.Given the nature of the procedure there was no technical incision made but the procedure had started.The surgeon and staff had to find alternate solutions to attempt the completion of the case prior to officially cancelling the procedure.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be debris from the worn material of the cube component on the working element.The material may have got lodged in the entry portal area for the electrode, causing the electrode to not lock in place.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the loop electrode would not lock into working element of the resectoscope.The surgeon and staff had to find alternate solutions to attempt the completion of the case prior to officially cancelling the procedure.Anesthesia was administered to the patient and there was no incision made.

• Brand Name: PKG, WORKING ELEMENT, PASSIVE
• Common Device Name: HYSTEROSCOPE AND 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22926765
• Report Number: 0002936485-2025-00752
• Device Sequence Number: 21390043
• Product Code: HIH
• UDI-Device Identifier: 07613327063561
• UDI-Public: 07613327063561
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K040390
• 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): 10/31/2025

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: 0502880401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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