MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-00

Device Problems Mechanical Problem (1384); Defective Component (2292)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a prestige grasper.During a diagnostic laparaoscopic procedure, it was noted that there was an insulation defect.There was a short delay in the surgery while another sterile instrument was opened.This malfunction did not cause patient harm or require intervention.Additional information was not provided.

Manufacturer Narrative

Manufacturer evaluation: the complaint device was returned to the manufacturer for physical evaluation.A visual examination revealed, that the device showed signs of repair (shrink tube).The device history records (dhr) were reviewed, for all available lot numbers.The devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released, according to documented procedures.And a device is not released, if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident was not able to determined, due to the condition of the returned device.Therefore, the investigation was not able to confirm, a device or production problem that would have resulted in the reported event.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8656322
• MDR Text Key: 146648660
• Report Number: 2916714-2019-00023
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: 8360-00
• Device Catalogue Number: 8360-00
• Device Lot Number: M54735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Distributor Facility Aware Date: 05/09/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1