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

Model Number	33310C
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damage to the insert was noticed by the medical device technician during processing.The instrument has been sent over to ssd (sterile services department) and it was discovered the end tip has broken off and neither theatre staff or ssd are aware of its whereabouts.It is not known if this instrument was broken during a procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During the investigation, the following was found: the ball socket at the proximal end is broken.There is material protruding from one side, which is a sign that the material has been bent, for example by lateral force.In addition, the item shows signs of wear and tear consistent with its age.According to the lot, the article was manufactured in december 2016, which would mean that the article is almost 9 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.Based on the available information and the results of the examination, there is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to and overloard situation in combination with wear and tear.The event is filed under internal karl storz 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 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22115439
• Report Number: 9610617-2025-00947
• Device Sequence Number: 4122842
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 04048551134092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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 Model Number: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: ZT10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 09/22/2025
• 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
• Patient Sex: Unknown