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

Catalog Number CAT02298

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

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 tip broke during the procedure.The device broke outside of the joint and the procedure was completed successfully.

Manufacturer Narrative

Alleged failure: it was reported by sales rep chelsea thomas that allegedly the nanopass tip broke while passing suture.Reportedly there was no patient harm and the case was completed successfully.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on device, 2) user technique related factors, or 3) 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.

Event Description

It was reported that the tip broke during the procedure.The device broke outside of the joint and the procedure was completed successfully.

• 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: 9118395
• MDR Text Key: 169071900
• Report Number: 0002936485-2019-00422
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: CAT02298
• Device Lot Number: 003655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1