MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CHAMPION SLINGSHOT 45 RIGHT; PASSER

Model Number CAT02855

Device Problem Expiration Date Error (2528)

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

Event Date 05/14/2020

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 an expired product was used in a procedure.

Event Description

It was reported that an expired product was used in a procedure.

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: expired product used probable root cause: design -validated shelf life too short application -distribution inefficient, sat too long in inventory before being shipped to customer the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.81.

• Brand Name: CHAMPION SLINGSHOT 45 RIGHT
• Type of Device: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10105121
• MDR Text Key: 193940629
• Report Number: 0002936485-2020-00214
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 07613327123692
• UDI-Public: 07613327123692
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT02855
• Device Catalogue Number: CAT02855
• Device Lot Number: 003180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1