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

Model Number	27050CA
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
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
It was reported that the plastic part of the resectoscope sheath had snapped off inside the patient.It was retrieved immediately but a part of the plastic was still attached to the sheath.Prolonged procedure for bleeding after turbt (return to theatre from recovery).Towards end of procedure, the broken off rim of the white plastic beak of resectoscope seen in bladder.Retrieved cystoscopically.Due to the bleeding and return to theatre from recovery the case is deemed reportable.
Additional Manufacturer Narrative
The device in question and additional device was returned to the manufacturer.This information is reflected in sections d1-d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the following was found out during the investigation on 01 aug 2025: after evaluating the available information, it can be assumed that the ceramic tip of the instrument broke during the surgical procedure.The most likely cause is a combination of mechanical overuse and incorrect use.As described in the instructions for use, damage to the shaft can have a negative effect on the ceramic tip.It is strongly recommended that the ceramic components be carefully inspected before each use to detect cracks, chips, or other damage at an early stage.If a damaged instrument is used nonetheless, this can significantly impair the stability and functionality of the tip.In addition to natural wear and tear, excessive force during the procedure may have led to breakage, especially if the instrument was already damaged or had not been inspected properly.The shaft of the instrument is damaged, which indicates a possible fall or mechanical impact.Such damage may have weakened the ceramic tip in advance, thereby promoting breakage during the procedure.The defect is therefore most likely due to a combination of external forces, possible previous damage, and an inadequate visual inspection prior to the procedure.To avoid similar failures in the future, it is necessary to consistently implement the inspection routines described in the instructions for use and to focus more on preventive maintenance of surgical instruments.It can be assumed that the incident was caused by incorrect use.There is no technical defect or product fault.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Common Device Name: INNER SHEATH FOR 27050 SC
• 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: 22634143
• Report Number: 9610617-2025-01302
• Device Sequence Number: 15765750
• Product Code: FJL
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2025

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: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: RN03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 08/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown