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

Model Number	27290M
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	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, the grasper, from one of the pcnl sets had broken during use.Reportedly, the instrument was functioning normally at the start of the case, but later the grasping mechanism stopped working.Upon inspection, it was clear the rivet / screw that secured one side of the jaw mechanism was missing.The scrub team had endeavored to find the missing piece, but were unable to do so, later on, in the pouch of the operation drape we have found a metal piece which could possible be the missing part of the forceps, x ray taken.Since additional x ray taken, this case is reportable.

• Brand Name: FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22340857
• Report Number: 2020550-2025-01068
• Device Sequence Number: 15718331
• Product Code: FGA
• UDI-Device Identifier: 04048551082508
• UDI-Public: 04048551082508
• 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): 06/26/2025
• Report Date (Section F): 06/26/2025

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: 27290M
• Device Catalogue Number: 27290M
• Device Lot Number: NY01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• 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