MAUDE Adverse Event Report: AESCULAP AG HI-LINE CRANIOTOME CUTTER II; HIGHSPEED POWER SYSTEMS

Model Number GD805R

Device Problem Break (1069)

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

Event Date 06/12/2020

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 the product hi-line craniotome cutter ii.Specifically, it was reported that material broke during two neurosurgical procedures.There was no patient harm.Additional information was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.A capa is not necessary.

• Brand Name: HI-LINE CRANIOTOME CUTTER II
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10245778
• MDR Text Key: 200659633
• Report Number: 9610612-2020-00285
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• 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: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD805R
• Device Catalogue Number: GD805R
• Device Lot Number: 52577601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1