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

Catalog Number	CAT02855
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: "during the capsular suture, the champion slingshot cat002855 (lot010509) broke.The broken piece was retrieved after approximately 15 minutes.There were no effects on the patient.Please check whether a material defect was the cause of the break." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user technique related factors, 2) difficult anatomy, extremely tough soft tissue, 3) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the champion slingshot broke.The broken piece was retrieved after approximately 15 minutes.There were no effects on the patient.
Additional Manufacturer Narrative
Alleged failure: "during the capsular suture, the champion slingshot cat002855 (lot010509) broke.The broken piece was retrieved after approximately 15 minutes.There were no effects on the patient.Please check whether a material defect was the cause of the break." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user technique related factors, 2) difficult anatomy, extremely tough soft tissue, 3) use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the champion slingshot broke.The broken piece was retrieved after approximately 15 minutes.There were no effects on the patient.

• Brand Name: CHAMPION SLINGSHOT 45 RIGHT
• Common Device Name: PASSER
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23652335
• Report Number: 0002936485-2025-00941
• Device Sequence Number: 4824526
• Product Code: HWQ
• UDI-Device Identifier: 07613327123692
• UDI-Public: 07613327123692
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CAT02855
• Device Lot Number: 010509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown