MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 70 DEG UP; PASSER

Catalog Number CAT02590

Device Problem Break (1069)

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

Event Date 05/22/2019

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 procedure.The tip was retrieved successfully.

Event Description

It was reported that the tip broke during procedure.The tip was retrieved successfully.

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: slingshot broke while closing capsule.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 re-occurrence.The device manufacturer date is not known.

• Brand Name: SLINGSHOT 70 DEG UP
• Type of Device: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8708614
• MDR Text Key: 148405808
• Report Number: 0002936485-2019-00240
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 07613252656616
• UDI-Public: 07613252656616
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT02590
• Device Lot Number: 003843
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1