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

Model Number 8360-10

Device Problems Break (1069); Material Separation (1562)

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

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

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 there was separation of the handle from the shaft of the grasper at the welded area.Additional information was not provided.

Event Description

No update required.

Manufacturer Narrative

Manufacturer evaluation: the complaint device was not returned to the manufacturer for physical evaluation.However, aesculap in partnership with the contract manufacturer have previously investigated and addressed similar issues of this nature (distal brazefailure/breakage).Previous investigations performed for similar failure modes revealed the following.The supplier 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 device history records (dhr) were not able to be reviewed as the lot number was not available.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.Although the complaint device was not returned for analysis, prior investigations performed for similarly reported events have confirmed this failure mode.Therefore, 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.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.

Event Description

No update required.

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 not returned to the manufacturer for physical evaluation.However, aesculap in partnership with the contract manufacturer have previously investigated and addressed similar issues of this nature (failed tug test/proximal weld separation).The device history records (dhr) were not able to be reviewed as the lot number was not available.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.The complaint device was not returned for analysis, and no lot number was made available, 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.However, prior investigations performed for similarly reported events have confirmed this failure mode.Therefore, this event likely occurred due to inadequacies in the defined production process which limited the device performance.The most probable root cause is considered to be manufacturing related.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.

Manufacturer Narrative

Corrected information: h10 during a comprehensive review of the reported event, it was noted that the failure mode was described as the devices being separated at the weld.As this failure mode was escalated to a reportable malfunction in october 2019, the subsequent investigation results require mdr reporting.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.All returned non-conforming devices exhibited the same weld failure; a clean break occurred from the solder to the rotator housing.An investigation of the device manufacturing records was conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.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.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.The investigation into the cause of the reported problem was able to confirm the failure mode of a proximal weld failure.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: 10334296
• MDR Text Key: 200849831
• Report Number: 2916714-2020-00295
• 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
• 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

• 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?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 07/06/2021; 07/29/2021; 08/13/2021
• Supplement Dates FDA Received: 07/06/2021; 08/02/2021; 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1