MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 011168-10 ELEKTRODE, BIPOLAR

Model Number 011168-01

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported that the customer had an issue with bipolar loops.3 have broken inside a patient.The surgeon said it was getting caught on the inner sheath of the resectoscope but was breaking without any force.Product was inside patient during surgery but had been retrieved by consultant.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The product in question is not sold in the u.S but a smillar product is sold in the united states.Therefore, a medwatch report is required for this incident.

• Brand Name: 011168-10 ELEKTRODE, BIPOLAR
• Type of Device: ELEKTRODE, BIPOLAR
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15747858
• MDR Text Key: 303548542
• Report Number: 9610617-2022-00298
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551411087
• UDI-Public: 4048551411087
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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: 011168-01
• Device Catalogue Number: 011168-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/07/2022
• 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