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

Model Number FORCEEZ-8C

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during radical resection of colon cancer, the device displayed garbled code and did not work.The issue occurred when the patient was undergoing right hemicolectomy to separate the tissue.The surgeon immediately replaced the dissector and complete the operation.Due to dissector malfunctioned, thus, prolonged the operation time, the patient's bleeding was increased.

• Brand Name: FORCE EZ
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10767468
• MDR Text Key: 214149243
• Report Number: 1717344-2020-01337
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521512085
• UDI-Public: 10884521512085
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEEZ-8C
• Device Catalogue Number: FORCEEZ-8C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR