MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT; PASSER

Model Number	CAT02298
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
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 device broke outside of the joint during the procedure.
Event or Problem Description
It was reported that the device broke outside of the joint during the procedure.
Additional Manufacturer Narrative
Note: the investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: dr.(b)(6) bent the first one slightly and was unable to trigger it afterwards.He did not offer the second one, but still it could not be triggered.The third one worked.Procedure could be completed successfully.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on device, user technique related factors, or difficult anatomy, extremely tough soft tissue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: NANOPASS REACH CRESCENT
• Common Device Name: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10198021
• Report Number: 0002936485-2020-00245
• Device Sequence Number: 14054674
• Product Code: HWQ
• UDI-Device Identifier: 07613252633204
• UDI-Public: 07613252633204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 09/09/2020

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: CAT02298
• Device Catalogue Number: CAT02298
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1