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

Model Number CAT02298

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2019

Event Type  Injury  

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 there was a potential for foreign material being left in the joint.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: black foreign material in lesion probable root cause: design - instrument tip not designed for insertion into cannula - improper raw material selection - assembly design not strong enough to withstand insertion effort manufacturing - incorrect raw materials used - instrument not manufactured to specification - instrument not assembled properly application - excessive force - user attempts to insert into cannula which already supports access of other instruments to the joint space - user attempts to insert device without use of a cannula the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that there was a potential for foreign material being left in 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
• MDR Report Key: 9438575
• MDR Text Key: 169882043
• Report Number: 0002936485-2019-00539
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT02298
• Device Catalogue Number: CAT02298
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other