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

Model Number 8360-10

Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

When additional information is received a follow up report will be submitted.Patient information: unknown.

Event Description

It was reported by the company sales representative "instrument will not close or hold tissue." additional patient information has been requested.When additional information is received a follow up report will be submitted.Incident did not cause serious injury or death.There was a 45 minute delay in surgery.There was no additional intervention required.

Manufacturer Narrative

Investigation results: (supplier).Root cause for escapement: the supplier performs 100% inspection visually of braze quality as per med-pd-as0-013 rev b(brazing subassembly instructions).The supplier also performs 100% torque test for braze strength and visual of braze quality as per med-pd-as0-014 rev b (aesculap tube sub-assembly torque testing procedure).There were no rejects reported for braze failures during the testing of this lot.However, the supplier determined that there was no method to report scrap at the brazing operation.Therefore, it is unknown if there were increased failures during this lot.The supplier also performs 100% final inspection which includes grip test with no reported failures for this lot.The supplier believes that had the defect been present at the time of shipment, the inspection methods would have captured the defect.Therefore it is believed that the defect was not present at the time of shipment.However, the strenght for the braze could have been not sufficient to withstand use within the field.Since manufacturing of the complaint lot, the supplier has incorporated an additional inspection of a variable first piece inspection per lot of the braze strength thru a destructive test on instron as per med-pd-as0-023 rev a (aesculap brazing pull test).The specification limit set for this is greater than 650 lbf.The implementation of the test was the result of med-pq-000-374a, which validated the implementation of flux during the brazing operation and identified a large range in strength results when brazing without flux.Root cause for occurence: the supplier reviewed defects related to the brazing process and determined that the complaint lot was manufactured prior to the implementation of flux.The implementation of flux was performed on (b)(6) 2018 as a result of the similar defect as the complaint (clean break at the braze join between the tube and the dovetail housing).The validation of the incorporation of flux was performed on med-pq-000-374a.Therefore the suspected root cause for occurence is the brazing operation being performed without flux.Corrective action for occurence: the root cause was determined to be related to the parts being processed prior to the implementation of flux.Since the shipment lot, the supplier has utilized flux on all brazing operations.Therefore there are no corrective actions required for this specific occurence at this time.Per supplier investigation, as documented in both cars, this reported issue was confirmed.Although it was reported to be a functional failure in the grasping of the device, the received device was found to be returned in a broken condition.Root cause (aesculap).Although this reported incident was reported prior to initiation of aesculap capa, it is noted that capa was issued in december 2019, to evaluate the design and production activities that were performed and documented for the prestige grasper product line (pn's: 8360-10, 8360-00, 8361-10, 8361-00).The activities included the documentation of manufacturing processes and controls and design transfer from prior manufacturer, to current contract manufacturer.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8337301
• MDR Text Key: 136143887
• Report Number: 2916714-2019-00003
• 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
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• 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: M45399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Distributor Facility Aware Date: 01/17/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other