MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI RECIPROCATING SAW; POWER SYSTEMS

Model Number GA674

Device Problem Component Incompatible (1108)

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

Event Date 04/28/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: 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 product acculan 3ti.Following information was reported on 28-apr-2019 that the patient had a coronary artery bypass graft surgery under general anaesthesia.During surgery it was found that spring of the sternum saw stuck out.Replaced with another normal device.Informed technician.There was no patient injury.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: an investigation is not possible because the device was not available for investigation.The device history records have been checked for the available lot number and found to be according to the specification valid at the time of production.No further complaints registered against the same lot number.After a review of the device history records, there is no indication for a manufacturing error.According to our database, the device was delivered in september 2012.A maintenance / repair was not registered since that date.In the instructions for use it is advised that a maintenance should take place at least once per year and based on the corresponding lase engraving.Abstract of the ifu (ta011474 - 12/09): " to ensure reliable operation, maintenance has to be carried out as indicated on the maintenance sticker [.]".In summary, the error is probably due to wear and tear.

• Brand Name: ACCULAN 3TI RECIPROCATING SAW
• Type of Device: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10296240
• MDR Text Key: 203521954
• Report Number: 9610612-2020-00305
• Device Sequence Number: 1
• Product Code: HAB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA674
• Device Catalogue Number: GA674
• Device Lot Number: 51869835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1