MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, ROTATABLE; ENDOSCOPE SHEATH

Model Number	26050XA
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	10/27/2023
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 while doing a resection under a gynae list.Where the karl storz gynae resectoscope sheath has melted and the ceramic beak has broken.Fortunately, the patient and safe and all debris were retrieved inside the patient's cavity.It was stated that a medical/surgical intervention was required to retrieve the broken parts.No death or (unanticipated) serious deterioration in state of health reported.Due to the medical intervention, a report is required.
Additional Manufacturer Narrative
The investigation of the product was completed on 2024-01-09.Based on the damage described, the breakage of the ceramic beak may have been caused by the inner stem being pulled out of the outer stem at an angle.If the inner shaft is pulled out of the outer shaft at an angle, this presses the ceramic against the outer shaft and can lead to breakage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH, ROTATABLE
• 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: 18156275
• Report Number: 9610617-2023-00375
• Device Sequence Number: 7999642
• Product Code: HIH
• UDI-Device Identifier: 04048551092668
• UDI-Public: 4048551092668
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/16/2024

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: 26050XA
• Device Catalogue Number: 26050XA
• Device Lot Number: ON03
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown