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

Model Number 8360-10

Device Problems Break (1069); Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation: as a result of an adverse trend for devices exhibiting failure at the thumb-loop assembly joint, a supplier corrective action request (scar) was initiated.The malfunction was evaluated by the supplier 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 this scar, a corrective action/preventive action (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 to aesculap that one (1) prestige atra grasper (part # (b)(4) ) device underwent a tug test in the central sterile processing department (spd) on october 6, 2020.According to the complainant, the proximal weld separated at the location of the handle.No patient involvement.The devices were available to be returned to the manufacturer for evaluation.

Event Description

Clarification was received: in addition to the failure of the weld during the tug test, the device was further damaged.During storage and preparation for shipment, the tip was bent and broken.

Manufacturer Narrative

If further details or investigation results become available, a supplemental report will be provided.

Manufacturer Narrative

Manufacturer evaluation: the complaint device was returned to the manufacturer for physical evaluation.A visual examination revealed that the device had a failure of the proximal weld.Additionally, the tube was found to be severely bent.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.However, the damage present on the returned device was indicative of the excessive force being applied during use.

Manufacturer Narrative

In addition to the failure of the distal weld during the tug test, the device was further damaged.The tip was separated at the distal end.The device was received for evaluation by the manufacturer and forwarded to research and development (tek park).Upon visual inspection, the reported event was confirmed for separation at the proximal weld.It was also discovered that the distal jaw was separated and the insulation was severely bent.The instrument did not have any etch information indicating the unit was repaired.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 nonconforming 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.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.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.The supplier also reviewed the work instructions (wi) for the tube sub assembly test procedure wi, the brazing procedure wi, and the brazed joint buffing wi and identified improvement opportunities.While the tube subassembly joint is 100% percent tested with a torsional force, there was no requirement for applying a bending force to the joint.Therefore, a manual bend test was added to the wi.Additionally, a review of the torque test fixture and accompanying wi, noted the potential for the tube to slip inside the collet during inspections allowing for a defective part to potentially pass this test.The tube sub assembly test procedure was further updated to note this potential failure mode and to define the process for cleaning the parts and fixture/collet with alcohol prior to use.A review of the brazing procedure wi revealed that the glass tube was too short to effectively seal the brazing area off from the surrounding environment.Without a proper seal the brazing area could have insufficient argon present to facilitate effective brazing.The brazing procedure wi was updated to include a check for this condition prior to brazing.Additionally, the supplier updated the wi to optimize the order of operations of when flux is applied, the soldering ring is assembled, and the tube is loaded.This change ensured that flux would be present throughout the entire joint space and allow for proper solder travel.Furthermore, a functional review and visual examination of the nest, which the tube sub assembly sits into, was performed.This review revealed that the two argon access holes were clogged.Therefore, the associated preventative maintenance activities were updated to monitor the access holes and prevent a recurrence of buildup.Finally, the supplier updated the brazed joint buffing wi to note the potential failure mode of excessive buffing, which could remove too much material and weaken the joint.The investigation into the cause of the reported problem was able to confirm the failure mode of proximal and distal weld failures.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.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: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10766530
• MDR Text Key: 214149462
• Report Number: 2916714-2020-00612
• 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,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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
• Device Lot Number: M45041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1