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

Model Number CAT02298

Device Problem Material Deformation (2976)

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

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

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. No manufacturing date - the device manufacturer date is not known.

Event Description

Per investigation results, the device was broken at the internal shaft. Per additional information received, the device bent inside the joint and when removed was attempted to be straightened and it broke. No pieces broke inside of the joint.

• Brand Name: NANOPASS REACH CRESCENT
• Type of Device: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 10153914
• MDR Text Key: 196006382
• Report Number: 0002936485-2020-00235
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 04/29/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial