MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FOREIGN BODY FORCEPS, 28 CM

Model Number	27071TJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that rology grasping forceps broke whilst being used.Attempted retrieval of broken piece, initially grasped with forceps but unable to find the piece when new forceps removed from scope.Patient x-rayed and no metal seen.Thorough examination with repeat cystoscopy done and no metal piece detected.Surgeons satisfied that the broken part was not retained and consultant surgeon informed.The procedure was completed without injury to patient and with around 15 mins delay.However, since the x ray was required, this case is reportable.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FOREIGN BODY FORCEPS, 28 CM
• Common Device Name: FOREIGN BODY FORCEPS, 28 CM
• 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: 25086721
• Report Number: 9610617-2026-01003
• Device Sequence Number: 21450917
• Product Code: OCZ
• UDI-Device Identifier: 04048551079119
• UDI-Public: 04048551079119
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K950434
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 27071TJ
• Device Catalogue Number: 27071TJ
• Device Lot Number: NP02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• 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