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

Model Number CAT02590

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

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 a piece of the device was left in the joint.

Event Description

It was reported that a piece of the device was 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: lower jaw of the slingshot broke off.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 reported failure mode will be monitored for future re-occurrence.

• 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: 9687519
• MDR Text Key: 178378805
• Report Number: 0002936485-2020-00056
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT02590
• Device Catalogue Number: CAT02590
• Device Lot Number: 004085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other