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

Model Number 26040GP1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device was recently returned but has not yet been evaluated.A supplemental report will be submitted once the evaluation has been completed.

Event Description

Allegedly, during a hysteroscopic myomectomy procedure, a piece of the electrode cutting loop broke off inside the patient.The broken piece was retrieved and procedure was completed with no impact on patient.

Manufacturer Narrative

Evaluation of the instrument confirmed that the wire loop has broken off the distal end; it is possible it was compromised by mechanical force; we cannot confirm.

• Brand Name: BIPOLAR CUTTING LOOP ELECTRODE
• Type of Device: BIPOLAR ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO, KG; mittlestrasse 8; 78503; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; dr.-karl-storz-strasse 34; 78532; tuttlingen,, CA ; GM ; 4242188201
• MDR Report Key: 7097899
• MDR Text Key: 94818825
• Report Number: 9610617-2017-00096
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 4048551392720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26040GP1
• Device Catalogue Number: 26040GP1
• Device Lot Number: NV04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1