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 03/27/2019

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.It was reported on (b)(6) 2019, during the routine preoperative inspection, the medical staff found that the handle of the self-stop craniotomy drill in the power system did not output after it was connected to the main body.After other handle was replaced, it returned to normal.Causing no adverse effects to the patient.There was no patient harm.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: the sample was not provided therefore an investigation is not possible.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.Based on the current information and without an investigation we assume that the failur is most probably not product related.According to the device history records there is no indication for a manufacturing or material error.A capa was not initiated.

• 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: 10296243
• MDR Text Key: 199733283
• Report Number: 9610612-2020-00306
• 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: 09/02/2020

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: 51792179
• 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