MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 22 FR.

Model Number 27026BA

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that the cystoscope sheath broke during a procedure.The sheath was inspected following the karl storz ifu before use for any dings, dents, damage and cleanliness.An obturator was also used to test if it could be inserted into the sheath smoothly.It was confirmed there was no damage prior to sterilization.No additional information was provided.

Manufacturer Narrative

Attempts to obtain more information and product for evaluation were made; however, the reporter has not indicated if product would be available for evaluation.Once the evaluation is completed, a supplemental report would be made to the fda.The reported complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(6).

Manufacturer Narrative

Per investigation by the manufacturing site: based on the customer's description of the fault, it can be assumed that the user is at fault.Since the item was not returned, no investigation can be carried out.One possible defect is that the soldered insert has come loose at the distal end.Since it is not known how old the item is, the material may have suffered material fatigue due to age, for example, which can lead to this type of fault.This event is filed under internal complaint (b)(4).

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Type of Device: CYSTOSCOPE SHEATH, 22 FR.
• 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: 18036190
• MDR Text Key: 326932826
• Report Number: 9610617-2023-00332
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: 27026BA
• Device Catalogue Number: 27026BA
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• 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