MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE EZ; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FORCEEZ-8C
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the laparoscopic radical gastric cancer surgery, the electrocoagulation hook was fired, exploded and the wire was blown off when used for hemostasis.The device was stopped and replaced with other high-frequency dissector for surgery.The explosion of the wire was in the grip of surgeon's right hand that caused the physician to be frightened.

• Brand Name: FORCE EZ
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 11600482
• Report Number: 1717344-2021-00491
• Device Sequence Number: 17049403
• Product Code: GEI
• UDI-Device Identifier: 10884521512085
• UDI-Public: 10884521512085
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: FORCEEZ-8C
• Device Catalogue Number: FORCEEZ-8C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR