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

Model Number 8360-10

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.The graspers x2 broke during normal usage and pressure of the surgery.The parts were found in the patient and removed.Ap and lateral taken to confirm all removed.The 2 jaws of prestige graspers at the end broke off.The parts were found in the patient and removed.All med watch submissions related to this report are: 2916714-2017-00027.

• 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: 7067057
• MDR Text Key: 93442129
• Report Number: 2916714-2017-00027
• 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: 11/29/2017

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?: No
• Distributor Facility Aware Date: 11/07/2017
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/29/2017
• 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: 45 YR
• Patient Weight: 89