MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, the circulating nurse was not able to open the device in a sterile manner.The paper tore as it was being pulled back and rendered it contaminated.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 9/3/2020.Investigation summary: the analysis results found that a harh36 device was returned inside its original package.Upon visual inspection, it was noted that the tyvek was adhered to the blister in the easy opening area.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique; however, no conclusion could be reached as to what may have caused this condition.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10217089
• MDR Text Key: 197148389
• Report Number: 3005075853-2020-03312
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: T9515M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 08/19/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE; GENERATOR AND HANDPIECE