MAUDE Adverse Event Report: AESCULAP AG HF COMBI UNIT 300W MONOP.80W.BIPOLAR; HIGH FREQUENCY UNITS

Model Number GN300

Device Problem Failure to Deliver Energy (1211)

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

Event Date 11/11/2019

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 hf combi unit.According to the complaint description during the process to separate tissues the electrotome had no output.Event happened during laparoscopic tension-free inguinal hernia repair surgery.A back-up device was used to continue surgery.There was no patient harm.Additional information was not provided nor available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).

Manufacturer Narrative

Investigation results: the device was not provided for investigation.Therefore a investigation of the device itself was not possible.The device quality and manufacturing history records (dhr) have been checked for the available lot number 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.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Based on the information received, the device was maintenanced at a third party service.For this reason we cannot guarantee a proper funvtion of the device.

• Brand Name: HF COMBI UNIT 300W MONOP.80W.BIPOLAR
• Type of Device: HIGH FREQUENCY UNITS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10466871
• MDR Text Key: 206807577
• Report Number: 9610612-2020-00447
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GN300
• Device Catalogue Number: GN300
• Device Lot Number: 52150732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1