MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, GRASPER, 5FR SEMI FLEX; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	0502555100
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
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 product broke.The broken pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
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: grasper broken.Probable root cause: manufacturing/assembly/ servicing error, severe shipping conditions, material/design error, damaged hardware/instrumentation, use error & constant irrigation flow is not maintained leading to limited field of view.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the product broke.The broken pieces were retrieved and the procedure was completed successfully.

• Brand Name: PKG, GRASPER, 5FR SEMI FLEX
• Common Device Name: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12001834
• Report Number: 0002936485-2021-00322
• Device Sequence Number: 3989345
• Product Code: FAJ
• UDI-Device Identifier: 07613327059595
• UDI-Public: 07613327059595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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 Model Number: 0502555100
• Device Catalogue Number: 0502555100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1