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  Injury  

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 se.

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).

• 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
• MDR Report Key: 17213291
• MDR Text Key: 317987931
• Report Number: 2020550-2023-00135
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2023
• Distributor Facility Aware Date: 05/25/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG