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

Model Number	33310C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the instrument was checked for functionality before being handed over.No damage was found.After the instrument was inserted, the branch was opened to lift the tube.The instrument jumped out of the holder and a metal splitter flew into the field of vision.The grasping forceps could no longer be opened or closed using the handle.After the metal splinter was recovered, it was held against the defective area.It was noticed that this was only half of an otherwise closed ring.A laparoscopic search was made for the missing part.Nothing was found.The patient's pelvis was then x-rayed.There were no abnormalities here either.

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18121269
• Report Number: 2020550-2023-00371
• Device Sequence Number: 15172314
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/13/2023
• Report Date (Section F): 11/13/2023

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: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: PS07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/09/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• 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