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

Model Number 8360-10

Device Problems Solder Joint Fracture (2324); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going: additional information / investigation results will be provided in a supplemental report when the information becomes available.

Event Description

It was reported that a prestige atra grasper dbl-act 5mm was received on under january 19, 2021 under aesculap technical services (ats) the customer requested a review of the device and inquired if the solder damage at the rotational handle was covered under warranty.Upon review by the aesculap technical service representative the solder looked as though it was the original soldering material and confirmed that the device is dislodged at the rotational block/handle.The device was transferred to quality control for shipment to the original equipment manufacturer for evaluation.This complaint involves a total of one (1) device.Additional information has been requested to determine when and where the device malfunction was initially noted and if there was any patient involvement, medical or surgical intervention required or delay in the procedure.

Manufacturer Narrative

A capa was opened by aesculap inc.For further evaluation of the design transfer of this device.Investigation results: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the seal between the handle and rotation mechanism appeared to be damaged.The device had considerable wear from use, but no debris.A functional evaluation concluded that the device handles accurately controlled the jaws and the rotation function worked as intended.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include rough sterilization processes, greater movement directed to the weld than anticipate, or wear from repeated use.No containment or corrective actions are recommended at this time.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11325065
• MDR Text Key: 233017030
• Report Number: 2916714-2021-00010
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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 Lot Number: L50557554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1