MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP

Model Number 27040GP130-S

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported there was a malfunction with a 27040gp130-s cutting loop, bipolar 0.3mm, 24/26 fr.According to the information received "the bipolar top broke off while being used in the bladder" patient harm is not known at the date of this report.It is not known if the broken piece remained in patients body.Additional information has been requested but not yet receives as of the date of this report.

• Brand Name: CUTTING LOOP, BIPOLAR
• Type of Device: BIPOLAR SINGLE USE CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• MDR Report Key: 17319552
• MDR Text Key: 319183386
• Report Number: 2020550-2023-00129
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: XN09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Distributor Facility Aware Date: 05/17/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other