MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY BIPOLAR CUTTING LOOP

Model Number 26040GP1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

The electrode has not been returned for evaluation.

Event Description

Allegedly, during a myomectomy procedure the doctor noted that the loop broke and fell into the patient.He did an x-ray and the results were negative.They searched through suctioned fluid and found it there.The hospital reported there was no injury to the patient.

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188519
• MDR Report Key: 6714374
• MDR Text Key: 80060442
• Report Number: 9610617-2017-00055
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2017

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: Physician
• Device Model Number: 26040GP1
• Device Catalogue Number: 26040GP1
• Device Lot Number: 53497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/14/2017
• 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: Initial
• Patient Sequence Number: 1