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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

The manufacturer's complaint reference number for this case is (b)(4).Se edwin carty reported that the doctor had 2 bipolar loops break during separate procedures.The loops completely came off the tip.No patient harmed during the procedure.Both loops from the same lot.First complaint is (b)(4).

Manufacturer Narrative

The affected product will not be returned, no evaluation results will be obtained.Based on the information provided by the facility that the tip came off the loop in the middle of a procedure, mechanical damage is a probable cause.The ifu 97000002usca 02-2019, states the product should not be manipulated or bent.

• 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
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 15508749
• MDR Text Key: 306353533
• Report Number: 9610617-2022-00273
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: 37CJ1218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 09/29/2022
• 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 Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 88 KG