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

Model Number HAR36

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.No lot or batch number was provided therefore a device history could not be done.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 plastic within the packaging was damaged.Making the scissors not sterile.There was no impact to the patient.

Manufacturer Narrative

(b)(4).Date sent: 7/22/2020.

Manufacturer Narrative

(b)(4) date sent: 8/18/2020 investigation summary the analysis results found that the harh36 device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged; it was noted to be broken and still adhered to the tyvek.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the damages found on the blister, a possible cause for this condition is due to improper handling during transit or storage; it appears that the package hit a hard surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.

• 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: 10209324
• MDR Text Key: 198874457
• Report Number: 3005075853-2020-03265
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• 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,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HARH36
• Device Lot Number: T9590J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Date Manufacturer Received: 07/28/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE