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

Model Number 8360-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Lot # is unknown at this time.

Event Description

It was reported that the jaws fell off the prestige grasper during a laparoscopic cholecystectomy.The physician had grasped the gall bladder with the endoscopic device and then it was noted that the jaws had detached.Although no injury occurred to the patient, there was a delay of 10-15 minutes during which time an x-ray was performed.The x-ray was used to retrieve the jaws from the abdominal cavity.Additional information was not yet provided.

Manufacturer Narrative

Investigation results: one 8360-10, 5mmx36cm atraumatic dual action grasper device returned.The complaint allegation stated: "the jaws of the device fell off inside the patient." the device components separated during an abdominal procedure.The identification and logo areas shows signs of bead blasting.Visual inspection confirmed broken jaw components.The jaws themselves were absent upon receipt, however, there is tape and a small packet attached to the device that was empty.Regardless, the distal portion of the device has been broken.The tip remaining is twisted and no longer aligned/centered with the luer port.The symptoms indicate excess torque was used.Per instructions for use: "aesculap prestige endoscopic graspers are designed to grasp soft tissue structures during endoscopic procedures.Aesculap endoscopic graspers are designed to be used through a cannula, or port, commonly called a trocar sleeve.Aesculap prestige endoscopic graspers are delicate surgical instruments.Any use of an instrument for a task other than its intended purpose will usually result in a damaged or broken instrument.Lateral pressure on the instrument when inserting or removing it may damage the shaft or the working tip." the condition may also occur during cleaning.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): CONTRACT MANUFACTURER: SMITH AND NEPHEW; 150 minuteman road; andover MA 01810
• MDR Report Key: 8111618
• MDR Text Key: 128632761
• Report Number: 2916714-2018-00039
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Distributor Facility Aware Date: 01/24/2019
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention