MAUDE Adverse Event Report: AESCULAP AG MICRO FLEXIBLE CABLE 2.3M; HIGH SPEED POWER SYSTEMS

Model Number GA173

Device Problem Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "during an ambulatory dental surgery the patient received a second degree burn to the wrist due to a cable overheating that was placed on the patient.It was also reported the cable will be returned.Additional information received reported the patient went home the day of the surgery and declared nothing.The patient declared the burn after and he treated himself.He came back at the end of the week with normal healing.

Manufacturer Narrative

Investigation: the investigation has been carried out by the aesculap technical services department (ats).After the inspection, no failure could be detected at the provided cable.After a test run of 5 minutes, no heating could be detected.Therefore we recommend to check the other equipment and tools (hand pieces) batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing failure.No further complaints registered against the lot number 51321891.Conclusion and root cause: the failure is not product related.No capa is necessary.

• Brand Name: MICRO FLEXIBLE CABLE 2.3M
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7915120
• MDR Text Key: 121912792
• Report Number: 9610612-2018-00430
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: K953968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA173
• Device Catalogue Number: GA173
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2018
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention