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

Catalog Number	CAT02298
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip broke during the procedure.All pieces were retrieved successfully.
Event or Problem Description
It was reported that the tip broke during the procedure.All pieces were retrieved successfully.
Additional Manufacturer Narrative
Alleged failure: tip break.Probable root cause: design inadequate raw material selection, tip geometry not designed to facilitate soft tissue penetration manufacturing, instrument tip or needle shaft not manufactured to specification, incorrect raw materials used for manufacture application, user technique related factors, difficult anatomy, extremely tough soft tissue.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.

• 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: 7996047
• Report Number: 0002936485-2018-00660
• Device Sequence Number: 1773939
• Product Code: HWQ
• UDI-Device Identifier: 07613252633204
• UDI-Public: 07613252633204
• Combination Product (Y/N): N
• 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): 12/21/2018

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: CAT02298
• Device Lot Number: 003286
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1