MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY AND GRASPING FORCEPS, 5 FR.

Model Number	26160UHW
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned on (b)(6) 2025 to 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).
Event or Problem Description
The customer claims the jaw was damaged/disconnected during the first time of use.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the customer complaint "jaw was damaged/disconnected" can be confirmed.The damage to the item is due to mechanical overload.By gripping material that was not intended for this purpose as there is a deformation on the tooth of the jaw.Too much force was applied to the joint part, causing it to break.The 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 e.G.Ifu: 97000045 v2.0 - 10 /2017 on page 2: warning: risk of injury: overloading the instrument by exerting too much force on it may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions.Ri: 26160uhw_en_v48.2_03-2023_ri_ce on page 14 10 visual inspection check products for the following points: - visible soiling - damage and corrosion - completeness - dryness 2.Subject any products displaying visible soiling to another complete cleaning and disinfection process.Discard damaged and corroded medical devices.Discard incomplete medical devices or replace missing parts.Dry the product by hand if necessary.Ri: 26160uhw_en_v48.2_03-2023_ri_ce on page 17 13.1 functional check if the device does not fulfill one of the points listed below or if damage can be identified, see chapter 'maintenance, repair, servicing and disposal' in the instructions for use.The following tests must be carried out to detect functional limitations: check the surface of the product for mechanical integrity and changes.Check the labeling for legibility.Check the product for mechanical integrity.Check the correct positioning of the assembled components and, if necessary, also check the cleaning connector.Check the mobility of all mobile components, if necessary once the components have been assembled in the case of products that can be dismantled.Check whether the end positions of the application part are reached.Check the cutting edge or tip for mechanical integrity.Check the fastening element for damage.Check whether the fastening element is suitable for the anticipated load to which it will be exposed by the intended application.The complaint history did not reveal any similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Common Device Name: BIOPSY AND GRASPING FORCEPS, 5 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: 21923283
• Report Number: 9610617-2025-00712
• Device Sequence Number: 4184233
• Product Code: GCJ
• UDI-Device Identifier: 04048551094679
• UDI-Public: 04048551094679
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K934937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 26160UHW
• Device Catalogue Number: 26160UHW
• Device Lot Number: SM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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