MAUDE Adverse Event Report: AESCULAP INC PRESTIGE ATRA GRASPER DBL-ACT 5MM; REUSABLE INSTRUMENTS

Model Number 8360-10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with a prestige grasper.During a laparoscopic appendectomy, the device fell apart causing fragments to fall into the surgical field.The surgeon had been using a one of the blunt graspers to provide counter-traction against the abdominal wall, while putting in a suprapubic port.After the first use, it appeared to be non-functional; the jaws would not open correctly and it was noted to be broken.One metallic piece was found within the patient and removed through a bag.An x-ray was also taken to confirm that all pieces were retrieved; results showed 1 additional fragment which was also removed.The second piece had fallen deep into mesenteric fat.The surgery was then completed successfully with one added port to finish the laparoscopic procedure.Additional information was not provided.

Manufacturer Narrative

A capa was opened by aesculap inc.For further evaluation of the design transfer of this device.Prestige: inspection.Etch information.Catalog number: 8360-10.Lot number: l5317599.Repair information: aes 03/20.Section: visual inspection.Nicks, scratches or defects.Other visible defects.Visual inspection summary: one (1) 8360-10 unit with lot number l5317599 was returned for investigation.There was etching indicating the unit was repaired by aesculap technical service (ats) in march 2020.It was confirmed that jaw components of the distal tip are missing.Upon further review, it was noted that the linkages inside the jaw housing are twisted.Physical inspection summary: physical evaluation is not warranted as the reported defect is visually confirmed.The root cause is either improper repair or manufacturing error.Section: conclusion.Confirmed.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10856066
• MDR Text Key: 217665581
• Report Number: 2916714-2020-00668
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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
• Device Lot Number: L5317599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention