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

Model Number 27026B

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that during a urological (emergency) procedure, there was an indication for endoscopic splinting of the right ureter.The necessary entry with the cystoscope was made more difficult by the presence of a pronounced erection.With blood clots present in the urinary bladder, the bladder had to be flushed with a bladder syringe to obtain adequate visualization.With a then clear view the broken end of the cystoscope shaft was visible in the patient's bladder, which could not be retrieved endoscopically due to its shape and size and was left in the bladder.This constitutes patient injury, as the broken part had to be retrieved in a second procedure using a lower abdominal incision.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Upon investigation of the affected product it could be confirmed that the tip has detached from the shaft at the distal end.Based on the lot number it could be determined that the date of manufacture is july 2010, which means that the item was over 13 years old on the date of the event (2023-11-17).It is concluded that due to the age and number of reprocessings of the device, the connection between the shaft and tip has been washed out over time, causing it to loosen.In addition, it was found during the examination that the article has a blow mark as well as a deformation (it is no longer straight) which may has favoured the loosening.

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• 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
• MDR Report Key: 18319673
• MDR Text Key: 330393669
• Report Number: 9610617-2023-00397
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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: 27026B
• Device Catalogue Number: 27026B
• Device Lot Number: UZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention