MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MANHES HIGH FREQUENCY NEEDLE FOR CUT AND COAGULATION

Model Number	30675ND
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); Burn, Thermal (2530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The name and location of the facility was not provided, and we have not received a report of this event from any of our customers; therefore, we have no further details of this event.We suspect the most likely cause of the injury was that the insulation on the device was already damaged/compromised prior to use in the procedure.Per the lot code provided (xv05), the instrument had likely been in use for over three years.
Event or Problem Description
Allegedly, as per medwatch #mw5080396 received from the fda, during a procedure in which a manhes high frequency needle was being used, when the cautery was used, the surgeon noted a small amount of smoke and a few small black fragments.The surgeon removed the device and they noted a small area on the instrument where the device had a break in the insulation approximately 1 cm from the tip.The surgeon then examined the patient laparoscopically again and noted a through and through burn to the patient's left fallopian tube.

• Brand Name: MANHES HIGH FREQUENCY NEEDLE FOR CUT AND COAGULATION
• Common Device Name: HIGH FREQUENCY NEEDLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8002219
• Report Number: 9610617-2018-00086
• Device Sequence Number: 16250317
• Product Code: GEI
• UDI-Device Identifier: 04048551123799
• UDI-Public: 4048551123799
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K972497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: 30675ND
• Device Catalogue Number: 30675ND
• Device Lot Number: XV05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1