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

Model Number HARH36

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

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

Event Date 07/30/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown surgery, before used on the patient, the package was found damaged.Changed to another one to complete surgery.There was no patient consequence reported.No additional information can be provided.

Manufacturer Narrative

(b)(4).Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the harh36 device was returned along with its package.Upon visual inspection of the package, the blister was observed damaged on a corner and a broken piece of blister still adhere to tyvek.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.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/23/2023.D4: batch # x94850 d4: batch # x94850.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16225250
• MDR Text Key: 308860036
• Report Number: 3005075853-2023-00444
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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: X94850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE.