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

Model Number	27040GP130-S
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2020550-2023-00129
• Device Sequence Number: 6188421
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2023
• Report Date (Section F): 06/16/2023

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
• Operator of Device: 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
• Distributor Facility Aware Date: 05/17/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/16/2023