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 Code	Laceration(s) (1946)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
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.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.Additional information received on june 13,2025: 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 (b)(6) hospital and is reported to be in stable condition.

• 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
• MDR Report Key: 22311540
• Report Number: 2020550-2025-01012
• Device Sequence Number: 9023837
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025
• Report Date (Section F): 06/23/2025

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: 27050XA
• Device Catalogue Number: 27050XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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