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

Model Number 8361-10

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the prestige graspers.There were a total of 6 graspers that malfunctioned for various reasons in one day.The reporter was not certain if they were found in sterile processing or during a procedure.This report is for the stem that was disconnected from the rotational housing.For the unspecified malfunction(s) that occurred during a laparoscopic cholecystectomy, there was no harm to the patient; however, a 30-minute delay was noted.Additional information was not provided.Associated medwatches: graspers reported separately per failure mode.

Manufacturer Narrative

Production date: 10/31/2018.Associated medwatches: graspers reported separately per failure mode (xc 1000024191).It was reported that the shaft separated from the joint area and the knob is detaching on several devices.The samples that were provided were sent to the supplier for evaluation.Results of the investigation show that the root cause was determined to be related to inconsistencies in the manufacturing process at the welding area for lots beginning with an "m".As a result, these complaints have been confirmed by the aesculap quality assurance team.Furthermore, aesculap is working with the supplier of these devices to institue appropriate corrective actions and control measures.As a result of an adverse trend for micro stamping devices exhibiting failure at the thumb-loop assembly joint, scar 19-003 had been issued for root cause and corrective action.

Manufacturer Narrative

Manufacturer evaluation: aesculap inc.Previously reported that a supplier corrective action request (scar) was initiated due to an adverse trend observed for devices exhibiting failure at the thumb-loop assembly joint.The supplier evaluated the malfunction by looking at devices with a lot number beginning with "m." as a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one.The complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed which confirmed separation at the proximal weld.All returned non-conforming devices exhibited the same weld failure; a clean break occurred from the solder to the rotator housing.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.In addition to the redesign of the soldering fixture, the supplier reviewed the work instruction for the torch soldering operation and identified improvement opportunities.The original work instruction was used to better define the soldering process with a more focused emphasis on the following: equipment startup and shutoff operations, clear imagery of acceptable soldered subassemblies, and clarified cleaning operations for components prior to soldering.A second dedicated work instruction was implemented to better define the attribute inspection criteria for the brazing process used for the solder between the thumb loop and rotator block.The investigation into the cause of the reported problem was able to confirm the failure mode of a proximal weld 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.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.

Event Description

No updates.

• Brand Name: PRESTIGE RETR GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9181085
• MDR Text Key: 162029503
• Report Number: 2916714-2019-00085
• 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,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8361-10
• Device Catalogue Number: 8361-10
• Device Lot Number: M46651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1