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 Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.Gyn surgery.Tip of instrument broke off into patient during surgery.Patient was not injured, but surgery was prolonged because patient had to be x-rayed in order to find the missing piece.Occurred during surgery.No patient harm.Surgical delay greater than 15 minutes while patient was under anesthesia because x-rays had to be done to locate missing piece.

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.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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, MA 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7095176
• MDR Text Key: 94514074
• Report Number: 2916714-2017-00028
• 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: 02/02/2018

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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/28/2017
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 02/02/2018
• 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