MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.

Model Number	26053CB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "during a procedure, the cutting loop of storz 15fr resectoscope sparked and disintegrated during a hysteroscopic myomectomy, creating a grey sediment inside the uterus.The surgeon noticed the loss/lack of ceramic tip on the sheath of the instrument and was not certain if the tip broke before or during the case." additional information received on 2025-03-10 regarding the patient condition: "the patient suffered an injury to the uterus, which caused the grey sediments.The patient will require a second operation in 4 to six weeks to check for uterine adhesions.".
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the adhesive bond between the ceramic insert and the shaft has come loose, allowing the ceramic insert to fall out.Ceramic insert was not provided for investigation.The inner sheath is seen as causal for the event.Due to the age of the inner shaft (production date august 2019) and the number of times it has probably been reprocessed, it can be assumed that the adhesive bond has come loose, for example during cleaning.This allowed the ceramic insert to fall out of the shaft end during use.As a result, there was no insulation between the electrode and the shaft, which caused the current to arc.Melting points at the tip of the shaft confirm this.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.This event is filed under internal complaint id: (b)(4).

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Common Device Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• 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: 21689181
• Report Number: 9610617-2025-00421
• Device Sequence Number: 9281969
• Product Code: HIH
• UDI-Device Identifier: 04048551410479
• UDI-Public: 04048551410479
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: VQ04
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 09/11/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/21/2025; 09/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26053SC RESECTOSCOPE SHEATH, 15 FR.LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown