MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DI SPIEZIO SARDO GRASPING FORCEPS

Model Number	26159DS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that they made 4 hysteroscopies and it is broken.After detailed instrument's examining we found that: apparently, the screw from the attachment point of the jaws is missing.Probably it's being lost somewhere.We couldn't find it.Since the breakage was discovered after procedure, it's possible the screw was lost.It is easy to see the absence of screw on the image: missing detail.No patient involvement and issue found after procedure.No negative impact in state of health reported.

• Brand Name: DI SPIEZIO SARDO GRASPING FORCEPS
• Common Device Name: DI SPIEZIO SARDO GRASPING FORCEPS
• 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: 25084343
• Report Number: 9610617-2026-01007
• Device Sequence Number: 10433963
• Product Code: GCJ
• UDI-Device Identifier: 04048551343289
• UDI-Public: 04048551343289
• Combination Product (Y/N): N
• Initial Reporter Country: MD
• 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,Consumer,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26159DS
• Device Catalogue Number: 26159DS
• Device Lot Number: YL01
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (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