MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number GB109

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 11/05/2020

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 to aesculap ag that a microline straight handpiece (part # gb109) was used during an oral surgery procedure performed on (b)(6) 2020. According to the complainant, the device generated heat when used in combination with another manufacturers bar. Reportedly, a large swollen burn occurred on the back of the patient's lips. The complaint device was available to be returned to the manufacturer for evaluation. Additional information was requested, but has not been made available. The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 10952337
• MDR Text Key: 252457319
• Report Number: 9610612-2020-00854
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GB109
• Device Catalogue Number: GB109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse