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

Model Number 8360-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while cleaning the instrument, the jaws came loose and fell off.The issue did not involve a patient or surgical procedure.

Manufacturer Narrative

One 8360-10, 5mmx36cm atraumatic dual action grasper device returned.This is a reusable instrument.The original packaging is absent.The product was returned with all parts; no apparent missing components.The dual action jaw mechanism is functional.Paddles are not damaged.The identification and logo areas shows signs of bead blasting.The complaint could not be confirmed since the device was functional.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): CONTRACT MANUFACTURER: SMITH AND NEPHEW; 150 minuteman road; andover MA 01810
• MDR Report Key: 8122247
• MDR Text Key: 129044577
• Report Number: 2916714-2018-00035
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

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 Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: L50378626
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/22/2019
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/01/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1