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

Model Number CAT02298

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2020

Event Type  malfunction  

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 Description

It was reported that the device broke outside of the joint during the procedure.

Event Description

It was reported that the device broke outside of the joint during the procedure.

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
• Type of Device: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10198021
• MDR Text Key: 196957311
• Report Number: 0002936485-2020-00245
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 07613252633204
• UDI-Public: 07613252633204
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1