MAUDE Adverse Event Report: AESCULAP AG CRANIAL PERFORATOR 12/15MM HUDSON SHANK; HIGHSPEED POWER SYSTEMS

Model Number GB304R

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was an issue with gb304r - cranial perforator 12/15mm hudson shank.According to the complaint description, the trepan did not stop after piercing the skull.The patient harm was unknown.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Updated: b5- patient harm updated to "no hazard".According to our evaluation, this event has been re-assessed and is considered no longer reportable; severity and failure have been reduced.

Event Description

Clarification: patient harm was updated to "no patient hazard".

• Brand Name: CRANIAL PERFORATOR 12/15MM HUDSON SHANK
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14469115
• MDR Text Key: 295149346
• Report Number: 9610612-2022-00130
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB304R
• Device Catalogue Number: GB304R
• Device Lot Number: 52450401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2018
• 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