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

Model Number 27026B

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2023

Event Type  Injury  

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).

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.

• 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
• MDR Report Key: 18319674
• MDR Text Key: 330393673
• Report Number: 2020550-2023-00397
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/13/2023

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: 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention