MAUDE Adverse Event Report: GYRUS ACMI, INC. HALO PKS CUTTING FORCEPS 5MM/33CM; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number HACF0533

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Gyrus halo pks cutting forceps 5mm/33cm did not function as expected when used during a laparoscopic bilateral salpingectomy.When the surgeon initiated the device after being plugged into console, there was no burning according to the surgeon.A new gyrus handpiece was obtained, added to the sterile field, and preformed as expected.

• Brand Name: HALO PKS CUTTING FORCEPS 5MM/33CM
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 12352761
• MDR Text Key: 267647087
• Report Number: 12352761
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HACF0533
• Device Lot Number: FR119455
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 76