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.The complaint allegation was for a failed grasper.It is indicated that the device fragmented during an intra-abdominal procedure.Visual inspection indicated fractured jaw components.This symptom indicates excessive force.This condition could occur during use or during cleaning.The identification and logo areas shows signs of bead blasting.

• 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: 8122262
• MDR Text Key: 129043108
• Report Number: 2916714-2018-00037
• 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: L50344199
• 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