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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Supplier: (b)(4).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, (b)(4), and a corrective action (scar) was performed.(b)(4) evaluated multiple batch # starting with m.(b)(4).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 a laparoscopic colorectal procedure the device did not close as expected while being used to grasp patient tissue.The device malfunction caused 5-10 minute delay.Additional information was not provided.

Event Description

No updates.

Manufacturer Narrative

Manufacturer evaluation: the complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed which confirmed the distal braze failure/breakage.All returned non-conforming devices exhibited the same failure; a failure of the braze that connects the tube to either the lower jaw or dovetail.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.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 investigation into the cause of the reported problem was able to confirm the failure mode of a distal braze failure/breakage.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.

• 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: 10420445
• MDR Text Key: 203459371
• Report Number: 2916714-2020-00334
• 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
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: M48596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1