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

Model Number	31310C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a part jaw part of the intestinal grasping forceps has broken off during procedure and remained in the patient.Further surgery was necessary to remove the foreign body.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections b5 and d9.Associated device 31300m clickline outer sheath was also returned by the customer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Information on surgery outcome: the foreign body has been completely retrieved; patient is doing well there are no lasting adverse consequences.
Additional Manufacturer Narrative
The investigation of the returned product revealed the following: 31310c: part of the jaw is broken due to excessive mechanical force.This can happen, for example, by squeezing the handle too hard (when grasping tissue).It can therefore be assumed that the user was at fault.The concomitant articles 38910md and 31300m show signs of wear but are not the cause of the incident mentioned.Since no critical and/or systematic deviation found during investigation no remedial/ corrective actions were taken.The customer will be informed and made aware of relevant warnings in the ifu.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 ; GM 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: 21214386
• Report Number: 9610617-2025-00039
• Device Sequence Number: 3326221
• Product Code: GCJ
• UDI-Device Identifier: 04048551333723
• UDI-Public: 04048551333723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/09/2025

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 Model Number: 31310C
• Device Catalogue Number: 31310C
• Device Lot Number: WM07
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 04/03/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/06/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 38910MD ROBI FORCEPS INSERT WITH OUTER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown