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

Model Number 8360-10

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Supplier: lot # was not provided, so the supplier was not identified.As a result of an adverse trend for devices exhibiting failure at the thumb-loop assembly joint, the malfunction has been investigated by the supplier, micro-stamping, and a corrective action (scar) was performed.Micro-stamping evaluated multiple batch # starting with m.Micro-stamping re-designed the push rod fixture, increasing the clearance, to ensure that the fixture is appropriately stressing the entire soldering joint.Upon implementing the new fixture, it was verified that the new fixture does not hang up on the soldering as the old one did when testing a returned non-conforming sample.In addition to this scar, a capa was opened by aesculap inc.For further evaluation of the design transfer of this device.Additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was an issue with a prestige grasper.During inspection and routine maintenance, separation of the weld was identified.Additional information was not provided.

Manufacturer Narrative

Manufacturer evaluation: aesculap inc.Previously reported that a supplier corrective action request (scar) was initiated due to an adverse trend observed for devices exhibiting failure at the thumb-loop assembly joint.The supplier evaluated the malfunction by looking at devices with a lot number beginning with "m." as a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one.The complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed which confirmed separation at the proximal weld.While the device displayed a clear failure mode, the lot number was not reported, therefore, the supplier was unable to substantiate this as being a supplier manufactured device.As a result, the investigation failed to confirm that a production problem resulted in the reported event, or that the complaint device exhibited the known thumb-loop assembly joint weld issue.Therefore, a definitive conclusion regarding the complaint incident was not able to be determined.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as lot # of the device in question was not known.However, 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.In addition to a supplier corrective action request (scar) being initiated, a field safety notice was issued to all customers requesting them to stress the proximal weld integrity of the device as a result of the supplier evaluation.Finally, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.

• 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: 10359000
• MDR Text Key: 202208093
• Report Number: 2916714-2020-00303
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1