MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG, CINCHLOCK SS ANCHOR WITH INSERTER; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number CAT02462

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that an expired product was used.

Event Description

It was reported that an expired product was used.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: expired implant used probable root cause: design insufficient labeling design insufficient shelf life validated application use past device/packaging shelf life the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: FG, CINCHLOCK SS ANCHOR WITH INSERTER
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16024089
• MDR Text Key: 307670974
• Report Number: 0002936485-2022-00776
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 07613252633228
• UDI-Public: 07613252633228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT02462
• Device Catalogue Number: CAT02462
• Device Lot Number: 21125AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1