MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH

Model Number 27050CA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It was reported that there was a malfunction with a 27050ca inner sheath for 27050sc.According to the information received, the ceramic beak broke inside patients bladder during a turp procedure.The piece/pieces were able to be removed with no direct harm to patient, however; an additional 30 minutes of anesthesia was added to the procedure.It was noted the possibility of a 3rd party repair was observed by (b)(6).

Manufacturer Narrative

Manufacturing site evaluation: the ceramic distal tip is broken/fractured with remaining attached beak having sharp, jagged edge.Lot code is tq 06((06/2019).Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).

Manufacturer Narrative

Per manufacturing evaluation: according to the customer, the ceramic beak was broken during the procedure.It is very likely that the article shows damage to the shaft due to use signs.In addition, the damage may have been caused by excessive force during use or signs of wear and tear.In this context, the ifu points out that damage to the shaft may have a negative effect on the ceramic beak.Therefore, it is pointed out in the instructions for use that you should check the ceramic components for damage such as cracks, chipping, etc.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: UROLOGY INNER SHEATH
• Type of Device: INNER RESECTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 east grand ave; el segundo, CA 90245 ; 4242188847
• MDR Report Key: 17182943
• MDR Text Key: 318124228
• Report Number: 9610617-2023-00135
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: TQ06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG