MAUDE Adverse Event Report: CONTRACT MANUFACTURER: SMITH AND NEPHEW PRESTIGE ATRA GRASPER DBL-ACT 5MM

Model Number 8360-10

Device Problem Material Fragmentation (1261)

Patient Problem Missing Value Reason (3192)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

During a total laparoscopic hysterectomy the tip of the grasper fell off.There was a 45 minute delay of the procedure, an x-ray was required.The broken piece of grasper was attempting to be retrieved from the patient when the piece was being pulled out, it hit the trocar and landed near the liver.The obgyn called 2 additional general surgeons to attend and remove the broken piece from the patient.Additional surgical entry points were required for removal.

Manufacturer Narrative

It was reported that during a total laparoscopic hysterectomy, the tip of the grasper fell off.Broken piece of grasper was attempting to be retrieved from the patient.When the piece was being pulled out, it hit the trocar and landed near the liver.The obgyn called 2 additional general surgeons to attend and remove the broken piece from the patient.Additionally surgical entry points were required for removal.This caused the procedure to extend for 45 minutes.X-rays were needed, no patient injury reported.Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not verified and a root causes could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.However, it the product is returned in the future the complaint can be reopened and evaluated.Should information become available this complaint can be re-assessed.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: GRASPER
• Manufacturer (Section D): CONTRACT MANUFACTURER: SMITH AND NEPHEW; 150 minuteman road; andover MA 01810
• MDR Report Key: 7916395
• MDR Text Key: 121988958
• Report Number: 2916714-2018-00022
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/27/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention