MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH45

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: v9560a.Additional information was requested and the following was obtained: does the damage to the package compromise the sterility of the device? from what i have seen there, there was no damage to the sterility.But this should be checked further.This is a analysis for a set of images submitted to ethicon endo surgery for evaluation.Images: the images provided by the customer are those where the blister appears to be deformed.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.The device was returned sealed inside its original packaging.Apparently it was exposed to high temperature.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.No conclusion could be reached as to what caused the reported packaging issue.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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 a bypass surgery the medical staff brought a harmonic 45 (harh45) device into the room for the purpose of harvesting a vein.Before opening the packaging of the harmonic device, they noticed that the packaging is damaged and looks defective.The above device was not used and another was taken in its place.The procedure was completed successfully.No harm was done to the patient and there was no delay in surgery.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 45
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13012193
• MDR Text Key: 288386261
• Report Number: 3005075853-2021-07771
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014638
• UDI-Public: 10705036014638
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH45
• Device Catalogue Number: HARH45
• Device Lot Number: V9560A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE