MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC; ENDOSCOPE SHEATH

Model Number	27050CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Result of investigation completed on october 29, 2024: according to the customer, the ceramic beak broke during the procedure.The article shows damage to the shaft due to use signs.The damage may have been caused by excessive force during use or signs of wear and tear.In this context, the ifu points out that damage to the shaft may have a negative effect on the ceramic beak.Therefore, it is pointed out in the instructions for use that ceramic components should be checked for damages such as cracks, chipping, etc.Before each use.The device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a material or manufacturing failure.The failure is most probably usage related.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that after a case of holmium laser enucleation of prostate and cystolithotripsy, a ceramic tip 0.9mm (l) and 0.8mm (d) of the resectoscope inner sheath was found broken with missing pieces during an instrument check before being transferred to the tssu.A search of the environment was conducted but in vain.The surgeon was informed afterward, a pelvic x-ray was performed and no obvious foreign body found.The patient was informed by the surgeon in ward.
Additional Manufacturer Narrative
Correction is provided in sections b1, b2, and h1.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).
Additional Manufacturer Narrative
Correction: the last supplemental report was to correct the severity of the event from malfunction to adverse event.The evaluation was completed and reflected in the initial report.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Common Device Name: ENDOSCOPE SHEATH
• 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: 20568818
• Report Number: 9610617-2024-00414
• Device Sequence Number: 7225205
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K221893
• 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): 11/08/2024

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: Other
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: ZO04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 10/18/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/06/2024; 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown