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

Model Number 27026 BA

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2023

Event Type  Injury  

Event Description

At 1745 on [redacted date] in or 8, dr.[redacted name] was performing a cystoscopy, left ureteroscopy, laser lithotripsy, stent placement and bladder biopsy.The cystoscope was inserted into the bladder to biopsy the questionable tumor and the protective hood on the 22fr metal sheath broke off in the bladder.The surgeon tried to retrieve the piece through the scope utilizing multiple ways and was unsuccessful.Dr.[redacted name] decided to convert to an open procedure to retrieve the broken piece utilizing a cystotomy approach and was able to successfully retrieve the broken piece, measuring 1.5 inches long.Spd was called, and [redacted name] the spd instrument lead came to the or to inspect the instrument and validated that this was indeed broken and unfamiliar with this potential hazard.The tip of the instrument that broke was sent to pathology for evaluation and requested to be sent to spd management once evaluation was complete for further evaluation as necessary.Additionally, the sheath was sent to fir for decontamination and the sheath is currently at the or control desk for evaluation as needed.The tray that contained this sheath was noted to be the cysto basic tray 014.Finally, an x-ray was taken at the completion of the procedure and read negative by the radiologist, dr.[redacted name].Harm to patient, foreign object retrieval, admitted to floor, unable to go home same day.Of note, similar reports to this in maude database from 2019 back to 2015.

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Type of Device: ENDOSCOPIC CONTAMINATION PREVENTION SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; 2151 e grand avenue; el segundo CA 90245
• MDR Report Key: 18300403
• MDR Text Key: 330161375
• Report Number: 18300403
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2023

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: 27026 BA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention