MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH 9FR; RESECTOSCOPE 9FR

Model Number 27033R

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue with the product 27033r resectoscope sheath 9 fr.According to the information received a piece of the resectoscope broke off in patient while undergoing a transurethral resection of urethral valves.After 40-45 minutes attempts were made to retrieve, the piece was eventually removed.A foley catheter was left indwelling to prevent clot formation and potential urinary retention.

Manufacturer Narrative

Initial evaluation findings found a broken ceramic tip with bubbling epoxy.The lot code of 10/2016 is over the manufacturers warranty period and is over 7 years old with signs of use.The event is filed under internal karl storz complaint id (b)(4).There are no other similar complaints filed in the same time period.The ifu states warning: sheaths with ceramic tips must be handled carefully.The sheaths must be checked for cracks or other damage each time they are used.Damaged sheaths (chips or cracks) must never be used, since malfunctions could occur which could lead to patient injury.Only use obturators specially designated for sheaths with ceramic ips.Unsuitable obturators may cause damage to the ceramic tip.

Manufacturer Narrative

Based on the damage found the ceramic insert broken off/broken out at the distal end, the breakage of the ceramic beak may have been caused by pulling the inner shaft out of the outer shaft at an angle.When the inner shaft is pulled out of the outer shaft at an angle this presses the ceramic against the outer shaft and can cause it to break.In addition, the ifu points out that the ceramic beak should be checked for damage before use.Most probable the root cause of the described failure is usage-related.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: RESECTOSCOPE SHEATH 9FR
• Type of Device: RESECTOSCOPE 9FR
• 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 e. grand avenue; el segondo, CA 90245 ; 4242188247
• MDR Report Key: 16583765
• MDR Text Key: 312197980
• Report Number: 9610617-2023-00064
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551232354
• UDI-Public: 4048551232354
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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: 27033R
• Device Catalogue Number: 27033R
• Device Lot Number: XT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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: 14 MO
• Patient Sex: Male
• Patient Weight: 11 KG