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

Model Number GB740R

Device Problem Device Damaged by Another Device (2915)

Patient Problem Brain Injury (2219)

Event Date 09/18/2020

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 a craniotome handpiece.According to the complaint description the bearing was damaged during surgery.The patient harm is currently unknown.Additional information was not provided nor available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).

Event Description

It was reported that there was an issue with a craniotome handpiece.According to the complaint description the patient received brain tumor excision under general anaesthesia.Milling cutter was used on skull.During operation bearing of the handpiece damaged and ball in bearing fell off.The bearing in the handpiece dislocated.Handpiece did not work properly.Additional information was not provided nor available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Reference code gb740r, device name hi-line xs craniotome handpiece, serial number (b)(6), batch number 4504734138, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 18.01.2013.Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: 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.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and measures / preventive measures: based on the provided information and without a product, a definitive root cause can not be determined.According to our database, the product was delivered in april 2013.A maintenance and/or a repair was not registered since that date.Furthermore, it was reported that the device was repaired/maintained by a third party.According to the corresponding ifu, a maintenance should take place on regular basis by the manufacturer and as indicated on the laser engraving on the product.On the basis of the current information and without the product for investigation, a clear conclusion cannot be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.Se.

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: 10707215
• MDR Text Key: 212514590
• Report Number: 9610612-2020-00694
• 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

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GB740R
• Device Catalogue Number: GB740R
• Device Lot Number: 4504734138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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