MAUDE Adverse Event Report: KARL STORZ SE & CO. KG GRASPING FORCEPS, 3 FR.

Model Number	11274FE
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that problem the jaws of the grasper broke off inside the patient.The broken foreign body was removed with another grasper and all pieces were confirmed removed from the patient.Staff also reported that the grasper often does not open when triggered by the procedurals.The procedure was completed successfully without delay.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device is not expected to be returned.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Device evaluation: as the device was not returned to karl storz tuttltlingen a physical examination was not possible.Furthermore, no lot number was provided, therefore a product history review could not be performed either.The labelling was found to contain adequate instructions and warnings.According to the customer's description, a part of the jaw of item 11274fe broke off in the body but could be recovered afterwards.A possible cause for this is that it was either not used for its intended purpose or broke due to mechanical overload.The item was not sent to kst for examination, so no precise statement is possible.The age of the item is also unknown, which has a significant impact on an article.If new or additional relevant information will be received, we will reopen the investigation accordingly.This event is filed under internal complaint id (b)(4).

• Brand Name: GRASPING FORCEPS, 3 FR.
• Common Device Name: GRASPING FORCEPS, 3 FR.
• 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: 21289193
• Report Number: 9610617-2025-00115
• Device Sequence Number: 9320719
• Product Code: OCZ
• UDI-Device Identifier: 04048551050545
• UDI-Public: 04048551050545
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11274FE
• Device Catalogue Number: 11274FE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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
• Patient Sex: Unknown