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

Model Number 8360-10

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.It was reported that during a laparoscopic appendectomy/cholecystectomy procedure, one side of the jaws of the laparoscopic prestige grasper broke off inside of the patient's abdomen.All pieces of the broken instrument were removed from the patient's abdomen.There was no harm to the patient.

Manufacturer Narrative

One 8360-10, 5mm x 36cm atraumatic dual action grasper device returned.The complaint allegation was for broken/detached jaws during an appendectomy/cholecystectomy procedure.Pieces were successfully retrieve per the surgeon.The device has indications of repair by an unauthorized third party.The original kynar outer tube coating has been replaced with shrink tubing.There is evidence of bead blast masking over etched areas.The locking handle fulcrum has been soldered.This is not a normal service.The jaw lug on one side of the dual action jaw has been damaged indicating excess force was placed upon the jaw lug track.Ifu indicates "instruments must be handled carefully during surgery and cleaning to avoid misusing the instrument." the repairs may have compounded the condition.No further investigation warranted.

• 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
• Manufacturer (Section G): CONTRACT MANUFACTURER: SMITH & NEPHEW; 150 minuteman road; andover MA 01810
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6545373
• MDR Text Key: 74476898
• Report Number: 2916714-2017-00003
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/04/2017
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other