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

Model Number	27050XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that a piece of a ceramic beak was found and removed from patient's bladder in (b)(6) 2024.It has been advised that the initial procedure was in 2019.Patient had experienced infections and pain post op 2019.
Additional Manufacturer Narrative
Device evaluation: a small fragment was received on november 27,2024 at the manufacturing site and was therefore available for investigation.The investigation has been completed on december 5, 2024.During the inspection, the following was found: only one broken ceramic insert was returned.It can be assumed that the breakage occured during the surgery by mechanical impact.It is unclear how old the article was at the time as no further information (e.G.Lot number) are available.Additionally, due to the size of the fragment, a full examination must remain incomplete.Furthermore, it is not possible to clearly identify whether the fragment originates from a karl storz product.Event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SL
• Common Device Name: INNER SHEATH
• 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: 20800927
• Report Number: 9610617-2024-00480
• Device Sequence Number: 20804063
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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