MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number R27040XA

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Reported device is being returned for evaluation.Once the evaluation is complete, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the inner sheath's insulate piece fell off in the patient's bladder.The physician removed the broken piece using theholmium laser and breaking it up.The physician then used an ellik to irrigate and got all the pieces out of the bladder.It was confirmed the physician removed all of the fragments.The surgery was continued and finished successfully.There was no report of injury to the patient.The was no issues with the device prior to the surgery.The autocon generator was set at 30/30 and bipolar 3/2 for the surgery.

Manufacturer Narrative

The reported device was not available for evaluation.It was reported that the ceramic insert had broken off/fallen out at the distal end.This may happen due to careless handling e.G.If the ceramic insert is weakened due to previous damage or if the ceramic insert was pressed against the wall during use by levering, as a result, a breakage can occur.In the corresponding ifu: 97000126; version: 3.0-03/2019 are warnings listed to not overload the instrument because of a possible breakage.In addition, it was pointed out that 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.Based on the above points, an operator error is assumed.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Type of Device: INNER SHEATH, FOR 27040 SD/SL
• 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 ; 4242188247
• MDR Report Key: 18421207
• MDR Text Key: 331633739
• Report Number: 9610617-2023-00405
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R27040XA
• Device Catalogue Number: R27040XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 150 KG