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

Catalog Number	33310C
Medical Device Problem Code	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
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).
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.

• 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
• MDR Report Key: 20582962
• Report Number: 2020550-2024-00432
• Device Sequence Number: 8714474
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 04048551134092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024
• Report Date (Section F): 10/31/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown