MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 091278-01

Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Narrative from staff: during flexible ureteroscopy with laser lithotripsy and stent exchange, surgeon was using disposable flexible ureteroscope.Digital picture from the scope was lost.Circulating nurse attempted to unplug the disposable ureteroscope and plug it back in with no success.Wire connections were checked, and the display imaging came back momentarily to be replaced by an inconsistent, fluttering, and grainy picture.

• Brand Name: URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill rd.; charlton MA 01507
• MDR Report Key: 15914680
• MDR Text Key: 304815593
• Report Number: 15914680
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2022

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 Catalogue Number: 091278-01
• Device Lot Number: 500484
• 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: 11/22/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 84 KG