MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number	31110C
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference numbers: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that customer was using a bowel grasper, handle 33126 (reference case (b)(4), shaft 31100 (reference case (b)(4) , insert 31110c (reference case (b)(4), and one of the jaws broke off inside of the patient.They were able to remove the broken piece.They just got another grasper to finish the case.Patient was not injured.No negative impact in state of health reported.
Additional Manufacturer Narrative
Information for section d10 was added.The aware date was added to section g-3.This event is filed under internal complaint id (b)(4) _ casenumber_(b)(4).
Additional Manufacturer Narrative
Correction in section g3 aware date is april 2,2025.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Product was returned on may 02, 2025.Will be forwarded to the manufacture for further evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal (b)(4).
Additional Manufacturer Narrative
Conclusion summary: it was confirmed that the jaws of the item complained about by the customer were broken.Slight changes in the material could be seen at the point of fracture.These show similarities to corroded areas.It was found that one side of the jaw at the distal end of the complained item had broken off.This could have been caused by microcracks in the material, which in turn could have been caused by the heavy use of the item.According to the lot, the article was manufactured in april 2022, which would mean that the article is 10 years old.Therefore, the most likely cause is that the chemical treatment cycles as well as the work cycles affected the instrument, causing the jaws to break due to the force applied during use of the instrument this event is filed under internal complaint id (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: CLICKLINE FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21886629
• Report Number: 9610617-2025-00668
• Device Sequence Number: 14313330
• Product Code: GCJ
• UDI-Device Identifier: 04048551333624
• UDI-Public: 04048551333624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/16/2026

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 Model Number: 31110C
• Device Catalogue Number: 31110C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/02/2025; 04/02/2025; 05/02/2025; 03/02/2026
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/05/2025; 05/12/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLICKLINE FORCEPS INSERT-31110C.; CLICKLINE PLASTIC HANDLE-33126.; CLICKLINE PLASTIC HANDLE-33126.
• Patient Sex: Unknown