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

Model Number 8360-10

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going, pending further information.

Event Description

It was reported that the laparoscopic grasper was sticking.No patient injury reported.No surgical delay reported.

Manufacturer Narrative

It was reported that the grasper is sticking.One atraumatic d&a grasper was returned for evaluation.Device was inspected per inspection procedure for mis instruments manufactured for or by smith &nephew inc.And the front end assembly was found not to rotate freely.The most likely causes is operator error as the part was either not assembled correctly or not checked 100% per assembly instructions.A re -training of the operator in question was performed.Further investigation is not warranted at this time.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): CONTRACT MANUFACTURER: SMITH & NEPHEW; 150 minuteman road; andover MA 01810
• MDR Report Key: 7877850
• MDR Text Key: 120397188
• Report Number: 2916714-2018-00019
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: L50703884
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/11/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1