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

Model Number	27071TJ
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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).
Event or Problem Description
It was reported that the device breaks every time surgeon tries to use it.No negative impact in state of health reported.
Additional Manufacturer Narrative
Updated section d9 to yes, and entered the device returned date to the manufacturer.The device was returned to our us facility on march 23, 2025.It will be forwarded to the manufacturing site for investigation.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
Updated section g3 adding aware date 04/23/2025.Correction to h11 verbage: the device was returned to our us facility on april 23, 2025.This event is filed under internal complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: it can be assumed that the pliers broke due to mechanical overload.Due to the dimensions of the item (diameter of 1 mm), the pliers must be used with appropriate care.Excessive force can therefore lead to such damage.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any similar complaints, no trend was identified.This event is filed under internal 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, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21869130
• Report Number: 9610617-2025-00641
• Device Sequence Number: 7841397
• Product Code: OCZ
• UDI-Device Identifier: 04048551079119
• UDI-Public: 04048551079119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 27071TJ
• Device Catalogue Number: 27071TJ
• Device Lot Number: YM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 04/23/2025; 02/09/2026
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/25/2025; 04/30/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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