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 uterus.The pt had severe bleeding due to poor coagulation.The pt lost 100cc's 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 information regarding the pt's condition but no information has been made available.

Manufacturer Narrative

The device referenced in this report was discarded by the user facility and will not be returned to olympus for evaluation.If additional information is received at a later time this report will be supplemented.

• Brand Name: PKS CUT FORCEPS, 5MM, 33CM, 9-PIN
• Type of Device: FORCEPS
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3767365
• MDR Text Key: 4468202
• Report Number: 2951238-2014-00152
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK): 920005PK
• Patient Outcome(s): Required Intervention