MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS,OPTICAL,STONE CRUSHING; LITHOTRIPTOR

Model Number	27074B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit in question was requested for return.The investigation is anticipated, but not yet begun.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the event occurred in (b)(6).During patient treatment, the jaw mechanism broke apart inside the patient.The surgeon then needed to investigate to find a fragment and x-ray to ensure no other fragments were left in the patient.No further fragments were detected, and the x-ray was clear.The operation was extended for 1.5 hours.(mfr's.Internal complaint # (b)(4)).
Additional Manufacturer Narrative
Upon the evaluation (dated 2021-12-20) it could be confirmed that the tie rod of the stone crushing forceps was bent and broken.The root cause is most likely that the forceps became damaged due to mechanical overload applied by the customer.According to the corresponding instructions for use (96216312df; version: 2.1 - 07/2018, chapter 3), it was written that overloading the instrument by exerting too much force may cause the medical device to break or bend.Bent instruments must not be bent back to their original position.

• Brand Name: FORCEPS,OPTICAL,STONE CRUSHING
• Common Device Name: LITHOTRIPTOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12738669
• Report Number: 9610617-2021-00071
• Device Sequence Number: 14477953
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: 4048551079386
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 27074B
• Device Catalogue Number: 27074B
• Device Lot Number: RQ05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown