MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27051 PL

Model Number	27051XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
They used the product not even 3 minutes and it broke in half - prior medical procedure there is no information that the event caused a harm or serious injury to patient, user or third.According to the new received information on 2025-04-07 the surgeon was able to do part of the surgery but not as he would have liked.
Additional Manufacturer Narrative
This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the customer's complaint can be confirmed.The shaft has broken off inside the bayonet.This is due to mechanical force being applied to the shaft tube.This caused the shaft tube to break.No comparable cases.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 FOR 27051 PL
• Common Device Name: INNER SHEATH FOR 27051 PL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21900440
• Report Number: 9610617-2025-00642
• Device Sequence Number: 4059373
• Product Code: FJL
• UDI-Device Identifier: 04048551078228
• UDI-Public: 04048551078228
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27051XA
• Device Catalogue Number: 27051XA
• Device Lot Number: XL03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/07/2025; 02/02/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/09/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male