MAUDE Adverse Event Report: GYRUS ACMI INC PKS CUT FORCEPS, 5MM, 33CM, 9-PIN

Model Number 920005PK

Device Problems Failure to Deliver Energy (1211); Failure to Fire (2610)

Patient Problem Blood Loss (2597)

Event Date 03/20/2014

Event Type  Injury  

Event Description

The user facility reported that during a laparoscopic supracervical hysterectomy the physician wasn't aware that the device was intermittently coagulating and would cut tissue as the pt had a very large coagulation.The pt lost 100cc's of blood from a bleeder and had to be given a unit of blood from a bleeder and had to be given a unit of blood.Another device was opened which also failed.The case was finished using a third device.Olympus has attempted to follow up to obtain further info regarding the pt's condition but no info has been made available.

Manufacturer Narrative

The cutting forceps were returned to olympus for evaluation.Evaluation confirmed the complaint.Visual inspection found the insulation damaged on all four electrodes and the flare cracked in four places where the electrode humps start to enter the shaft when the jaws were closed.The jaws open/close, the blad advances/retracts and the lock functions as designed.The bare sports on the electrodes were shorting cut on the shaft where the flare was cracked.The root cause was inconclusive and unable to be determined.The device history record showed no discrepancies.

• Brand Name: PKS CUT FORCEPS, 5MM, 33CM, 9-PIN
• Type of Device: FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 3824484
• MDR Text Key: 4403342
• Report Number: 2951238-2014-00164
• Device Sequence Number: 1
• Product Code: HFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 920005PK
• Device Catalogue Number: 920005PK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 920005PK/ PKS CUT/ FCP, 5MM/33CM 9-PIN (5/PK)
• Patient Outcome(s): Required Intervention