MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT; RIGID ENDOSCOPIC TISSUE MANIPULATION

Catalog Number	33310C
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip of the bowel grasper snapped off during use inside a patient.Caused the procedure to be prolonged by 3 hours while retrieving small bit that had come off.Since the procedure was prolonged by 3 hours and no information if the broken part was fully retrieved, this case is reportable as precaution.Cross reference mdr: 9610617-2024-00429.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The investigation shows that, based on the customer's description, user error is the likely cause.Compared to previous complaints, it appears that a branch of the mouthpiece broke, potentially due to excessive force.Additionally, the unknown age of the insert may have contributed to material breakage.However, as no article was provided, a detailed investigation could not be conducted.The diagnosed issue is not caused by a production defect.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20583043
• Report Number: 9610617-2024-00432
• Device Sequence Number: 8171169
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 33310C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown