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 Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Although the batch number was not provided, the supplier was identified as teleflex medical.Additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was an intraoperative issue with a prestige grasper, as per information received via medwatch (b)(4).During a laparoscopic cholecystectomy procedure, the device tip bent while it was inside the patient.It was pulled out of the trocar and would not fit back into it.Once everything was pulled out together, it "broke." an x-ray confirmed that there were no retained objects.The malfunction occurred in (b)(6) 2020.Additional information was not provided.

Event Description

No update required.

Manufacturer Narrative

Additional information - block d4 (udi), d7a, d8, d9.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.

• 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: 9953660
• MDR Text Key: 194202868
• Report Number: 2916714-2020-00095
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/16/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR