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

Model Number	27050XA
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Laceration(s) (1946); Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Information was received from the customer that the product will not be returned.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that according to the initial information, the instrument broke during surgery.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device will not be returned for investigation to the manufacturer.Should additional information / investigation results become available, a supplemental report will be submitted.Additional information was received and added in section b5.Additional concomitant medical products have beed added in section d10 will not be returned for investigation to the manufacturer.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information: detailed event description received from kse korea: "toward the end of the surgery, during preparation for coagulation, cutting loop 011160-01 was being replaced with 011169-01.The procedure involved disconnecting a working element that was assembled with 27050sl and 27050xa.During the disconnection process, the rotating part of the 27050xa (inner sheath) was found to be torn.As a result, the tip of the cutting loop was caught in the sheath and broke off, causing device damage.To examine the surgical site, the endoscope was reinserted, and fragments of the torn sheath and the broken tip of the cutting loop were found inside the bladder.During the removal of these fragments, an injury occurred, resulting in a bladder tear." it was furthermore stated that the patient was immediately transferred to eunpyung st.Mary's hospital and is reported to be in stable condition.
Additional Manufacturer Narrative
Result of investigation: the products involved in the event were not returned for investigation.Therefore, a physical investigation was not possible.The investigation was conducted based on a photo provided by the customer showing the damaged product 27050xa inner sheath.It is visible on the photo that the inner sheath is broken at the rear section of the slats.The exact age of the sheath cannot be determined as the lot is not known.It is possible that over the period of use and reconditioning, the material properties may deteriorated accordingly.In addition, mechanical overload can lead to breakage of the slats.Based on the event description it is concluded that as a result of the broken sheath, the sling/electrode was damaged when the working element was pulled out.Since none of the products involved in the event were returned, an exact root cause could not be determined.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SL
• Common Device Name: INNER SHEATH FOR 27050 SL
• 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: 22194817
• Report Number: 9610617-2025-01012
• Device Sequence Number: 18576801
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 27050XA
• Device Catalogue Number: 27050XA
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 02/10/2026
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/23/2025; 02/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 011160-01.; ARTICLE: 011169-01.; ARTICLE: 27050SL.; ARTICLE: WORKING ELEMENT (ARTICLE-NO. UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown