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

Model Number 8360-10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available, a supplement will be submitted.

Event Description

It was reported that there was an intraoperative issue with a prestige grasper.During a laparoscopic cholecystectomy procedure, the jaws of the device broke into 2 pieces and fell inside the patient's abdomen.The first fragment was easily removed using another grasper.The second piece was more difficult and a laparoscopic retrieval bag was required.All fragments were successfully removed and there was no further patient harm.An intervention was required.There was a slight surgical delay.Additional information had been requested.

Manufacturer Narrative

Updates: d9 product receipt date: the device was returned to the manufacturer and evaluated at tek park for distal tip separation.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as no lot # was provided by the complainant.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.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.Previous investigations performed against devices returned with distal braze failures identified improvement opportunities following a review of the tube sub assembly test procedure work instruction (wi), the brazing procedure wi, and the brazed joint buffing wi.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 visual inspection at tek park noted nicks, scratches and defects; upper and lower jaw disassembled from the jaw assembly.Orange tape had been applied to the instrument handle.The button which connects the thumb loop and finger loop is damaged and is seated unevenly in its mating hole.Laser markings were faded and masked which suggested that this instrument was repaired.Functional testing revealed instrument function was not smooth and consistent.The complained failure of the device was confirmed.Based on prior evaluations of complaint devices reported with a failure mode of distal braze break/separation, this event likely occurred due to inadequacies in the defined production process which limited the device performance.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
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 11253665
• MDR Text Key: 231121349
• Report Number: 2916714-2021-00006
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/12/2022
• 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
• Patient Outcome(s): Required Intervention