MAUDE Adverse Event Report: CODMAN SHURTLEFF, INC. CODMAN ISOCOOL AHT; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 8135050S

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Event Description

The isocool forceps were about to be used and blue fleck fell into the wound.Piece became stuck to filum, was taken out with the filum.The isocool forceps seemed to be intact.No evidence of delayed case or harm to the patient.

• Brand Name: CODMAN ISOCOOL AHT
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CODMAN SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8407269
• MDR Text Key: 138356797
• Report Number: 8407269
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8135050S
• Device Catalogue Number: 8135050S
• Device Lot Number: J0513A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA