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

Model Number 8360-10

Device Problems Break (1069); Solder Joint Fracture (2324); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going: additional information / investigation results will be provided in a supplemental report when the information becomes available.

Event Description

It was reported to aesculap inc.That a prestige atra grasper (part # (b)(4)) was to be returned for repair.On (b)(6) 2021, the device underwent a preliminary evaluation by aesculap technical services (ats) which identified wear with separation/breakage at the weld.Although requested, additional information has not yet been received.Should additional details become available a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation: two (2) prestige graspers were received for evaluation of proximal weld separation with lot number m48907; repair information was not available.The investigation was performed at aesculap tek park.Visual inspection summary: on both devices, the solder around the rotator housing had separated from the thumb loop.Solder material has remained attached to the instrument handle but separated completely from the rotator housing.Additionally, adhesive seems to be leaking out of the interface between the flush port assembly and the rotator housing.Additionally, the jaws on one of the two instruments appear to be misaligned.Physical and functional inspection summary: the returned devices were evaluated per spec-aic-5000100, version 3.0.The instrument handle easily separates from the rotator housing.This damage prevents the full openning and closing of the instrument jaws and results in rough actuation of the jaws.No further tests were performed beyond the test to confirm the complaint failure "rotator housing solder failure".Conclusion: the failure mode of proximal weld failure was confirmed.This event likely occurred due to inadequacies in the defined production process which limited the device performance.Therefore, the most probable root cause is considered to be manufacturing related.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.In addition to the redesign of the soldering fixture, the supplier reviewed the work instruction for the torch soldering operation and identified improvement opportunities.The original work instruction was used to better define the soldering process with a more focused emphasis on the following: equipment startup and shutoff operations, clear imagery of acceptable soldered subassemblies, and clarified cleaning operations for components prior to soldering.A second dedicated work instruction was implemented to better define the attribute inspection criteria for the brazing process used for the solder between the thumb loop and rotator block.In addition to a supplier corrective action request (scar) being initiated, 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: 11339691
• MDR Text Key: 233016945
• Report Number: 2916714-2021-00019
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• 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: 10/04/2021

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: 8360-10
• Device Lot Number: M48907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1