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

Model Number 8360-10

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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 problem with the side lock.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

H4 production date: 01/31/2019.Associated medwatches: graspers reported separately per failure mode (xc 1000024191) - this report was for "problem with side lock" 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: the complaint device was returned to the manufacturer for physical evaluation.A visual examination revealed that the device showed no visible issues.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.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.A definitive conclusion regarding the complaint incident was not able to determined due to the condition of the returned device.No device issues were identified with the returned device.

Manufacturer Narrative

Further evaluation and investigation was performed: the original complaint was reported, as functional "side-lock" issue.One (1) 8360-10, with lot number m47462 was returned for investigation.The instrument did not have any etch information, indicating the unit was repaired.Upon visual inspection, there was no obvious visual defect that could contribute to the slide lock mechanism failure.Functional testing showed, that the instrument function is not smooth and consistent.There was binding and locking mechanism failure.The device was physically evaluated.And the reported failure was confirmed.There was binding in the interaction between the handle and the locking mechanism.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.

• 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: 9181082
• MDR Text Key: 162029473
• Report Number: 2916714-2019-00098
• 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,Followup
• Report Date: 06/03/2021

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: M47462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 02/26/2021; 05/26/2021
• Supplement Dates FDA Received: 11/29/2019; 03/27/2021; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1