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.

Manufacturer Narrative

The device was forwarded to the original manufacturer, for evaluation.The investigation determined the probable cause of the malfunction was associated with application error at the end user in the form of excessive pressure being applied to the instrument.The manufacturer has determined there is no cause for corrective action at this time.There is no cause for containment.Aesculap will continue to monitor for reoccurrence.

• 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: 7067062
• MDR Text Key: 93441992
• Report Number: 2916714-2017-00026
• 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: 01/10/2018

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: 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
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 89