MAUDE Adverse Event Report: GYRUS ACMI HALO PKS CUTTING FORCEPS

Model Number HACF0533

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

Event Description

Gyrus acmi halo pks cutting forceps would not cauterize.Generator was checked, and plug was repositioned.Surgeon tried both grasping more tissue, and grasping less tissue, but the device would still not function.

• Brand Name: HALO PKS CUTTING FORCEPS
• Type of Device: CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI; southborough MA 01772
• MDR Report Key: 7471958
• MDR Text Key: 106910584
• Report Number: MW5076840
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2020
• Device Model Number: HACF0533
• Device Catalogue Number: HACF0533
• Device Lot Number: JF667957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR