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.

Manufacturer Narrative

Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 18677398
• MDR Text Key: 335023295
• Report Number: 9610617-2024-00034
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization