MAUDE Adverse Event Report: AESCULAP AG HI-LINE XS CRANIOTOME HANDPIECE; HIGHSPEED POWER SYSTEMS

Model Number GB740R

Device Problems Mechanical Problem (1384); Defective Component (2292)

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

Event Date 09/17/2019

Event Type  Injury  

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 hi-line xs craniotome handpiece.According to the complaint description the handpiece did not work.During cerebral mass exicion surgery while performing skull milling the handpice did not work.Internal bearing of the handpiece was dislocated.Surgery was continued with another handpiece.This event prolonged the surgery for a couple of minutes.This might result in permanent harm to body function or permanent damage to body structure.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.A clear conclusion can not be drawn.It is possible that wear and tear in combination with a third party repair/maintenance led to the described failure pattern.

Manufacturer Narrative

Additional information/correction: b5 - patient harm updated to "none".After receipt of additional information and clarification that there had been no patient harm, the complaint was re-assessed and determined to no longer be reportable (no malfunction nor serious injury).

Event Description

Update: information was received which confirmed that there had been no patient harm.

• Brand Name: HI-LINE XS CRANIOTOME HANDPIECE
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10466532
• MDR Text Key: 204918479
• Report Number: 9610612-2020-00430
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB740R
• Device Catalogue Number: GB740R
• Device Lot Number: 4506019745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 05/04/2023
• Supplement Dates FDA Received: 10/02/2020; 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2014
• 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
• Patient Outcome(s): Required Intervention