MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Model Number	27074B
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 a stone crushing forceps would not close after a stone was lodged inside the jaws.This meant that the instrument couldn't be removed from the sheath during a cystoscopy.The surgeon had to revert to an open procedure to free the stone from the instrument so that it could be safely passed back through the cystoscopy sheaths.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: in this case, an application error must be assumed.Based on the customer's description "a stone crushing forceps wouldn't close after a stone was lodged inside the jaws", it can be assumed that the stone was caught in the rear area of the tongs and became wedged in the teeth of the tongs, making it impossible to open and close.The excessive force may have caused the material of the pull rod to "stretch".Material fatigue may also occur due to the age of the materials.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• Common Device Name: 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: 19139742
• Report Number: 9610617-2024-00114
• Device Sequence Number: 8445411
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: 4048551079386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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: 27074B
• Device Catalogue Number: 27074B
• Device Lot Number: VY
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 06/12/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/10/2024; 07/01/2024
• 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