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

Model Number 26040GP1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned for evaluation as it was disposed of by customer.It is possible that the broken piece was removed with resected tissue.The cause of breakage cannot be determined without an evaluation.Possible causes are: using too high of a setting on the esu, or mechanical manipulation of the loop when not activated.

Event Description

Allegedly, the electrode loop broke off in the patient during a procedure.X-ray was done afterwards and they did not see the broken piece in the patient.

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; mittlestrasse 8,; 78503; tuttlingen
• Manufacturer (Section G): KARL STORZ GMBH & CO, KG; mittlestrasse 8; 78503; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6981914
• MDR Text Key: 91102533
• Report Number: 9610617-2017-00088
• 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
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 88