MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, ANGLED, 24 FR

Model Number 27040G

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 01/21/2024

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the item broke during the procedure and remained inside the urethra.The rest of the electrode remained inside the urethra.During the removal of the broken off part from the urethra, the urethra was damaged, which required the patient to be hospitalized for two more days.

• Brand Name: CUTTING LOOP, ANGLED, 24 FR
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18677397
• MDR Text Key: 335074506
• Report Number: 2020550-2024-00034
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/09/2024

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: 27040G
• Device Catalogue Number: 27040G
• Device Lot Number: XN17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization