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

Model Number 8360-10

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with the prestige grasper.In a robotic uterine myomectomy procedure, the tip broke during positioning.It occurred after introduction of the instrument into the trocar.The jaw broke off; the pieces were retrieved and did not fall into the patient's abdomen.The surgery was completed successfully with another device.There was no patient harm or intervention required.

Manufacturer Narrative

D section: batch # updated; supplier confirmed as (b)(4).Manufacturing evaluation: additional information / investigation results will be provided in a supplemental report, if applicable.

Manufacturer Narrative

Additional information - d4 (udi), h7 corrected information - d4 (lot #) manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.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.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, 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.

Event Description

No update required.

• 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
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 6109849072
• MDR Report Key: 9532043
• MDR Text Key: 173287655
• Report Number: 2916714-2019-00143
• Device Sequence Number: 1
• Product Code: NWV
• 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,Followup
• Report Date: 11/15/2021

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: L50510290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 11/02/2021
• Supplement Dates FDA Received: 03/30/2020; 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1