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

Model Number 8361-10

Device Problem Physical Resistance/Sticking (4012)

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 stiff rotation.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) this report was for "stiff rotation".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 institute 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 device was returned to the manufacturer for physical evaluation.A visual examination of the device was performed which revealed that no visible damage was present.Functional testing was performed which revealed that the handle action was not smooth, the handle rotation was rough, and the instrument function was not smooth or consistent.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.The investigation into the cause of the reported problem was able to confirm the failure mode of instrument function was not smooth or consistent.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
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 9181083
• MDR Text Key: 162029378
• Report Number: 2916714-2019-00084
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

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: 8361-10
• Device Catalogue Number: 8361-10
• Device Lot Number: M46651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 12/31/2021
• Supplement Dates FDA Received: 11/29/2019; 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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