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

Model Number 8360-10

Device Problem Material Integrity Problem (2978)

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

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

During a comprehensive review of the reported event, it was noted that the failure mode of this device was described as the device being detached at the distal shaft from the working end, beneath the insulation.As this failure mode was escalated to a reportable malfunction in november 2017, the initial information and subsequent investigation results require mdr reporting.The complaint device was returned to the manufacturer for physical evaluation.A visual examination showed there was no etching indicating the units were repaired by ats.There were no visible defects noted.Functional testing was conducted and the returned device met the functional grip test.The jaw remained intact and there was no misalignment.However, the unit failed for smooth and consistent function.The locking mechanism and the handle action was not adequate.Therefore, although the unit passed the grip test, it is confirmed that the device does not meet complete specification.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.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

It was reported that there was an issue with a prestige grasper.This was identified by aesculap technical services (ats); the distal shaft had detached from the working end beneath the insulation.There was no patient harm.

• 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
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 12078187
• MDR Text Key: 260969354
• Report Number: 2916714-2021-00106
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2021

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
• Device Lot Number: M48279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1