MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR CUTTING LOOP; CUTTING LOOP 24/26 BIPOLAR

Model Number 27040GP140-S

Device Problems Break (1069); Material Separation (1562)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

During a turp, 90 minutes into the procedure the doctor noticed the loop thinning, at which time the loop broke inside the patient.The broken piece was removed with no harm to patient.The procedure was completed with another loop.

Manufacturer Narrative

The product has not been returned by the facility, therefore no evaluation has been completed.

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: CUTTING LOOP 24/26 BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14885757
• MDR Text Key: 295136504
• Report Number: 9610617-2022-00104
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393208
• UDI-Public: 4048551393208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2020

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 Model Number: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male