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

Model Number 8360-10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.It was reported that during a surgical procedure the grasper were not holding tissue.Grasper slipped and punctured patient's liver.Additional time, products required to achieve hemostasis.There was injury to the patient, bleeding, and puncture of liver.There was a 30 minute delay of surgery.

• 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
• MDR Report Key: 7571505
• MDR Text Key: 110171453
• Report Number: 2916714-2018-00015
• 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
• Report Date: 06/05/2018

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: No Information
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: L50490670
• Distributor Facility Aware Date: 06/01/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 81 YR