MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH23

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

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u9525n.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.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.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 quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance related to the reported complaint condition were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

Event Description

It was reported that during an unknown procedure the packaging was damaged.There were no patient consequences.

• Brand Name: HARMONIC ACE PLUS 7 ADV HEMOSTASIS 23
• 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: 12977678
• MDR Text Key: 286930122
• Report Number: 3005075853-2021-07595
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014676
• UDI-Public: 10705036014676
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH23
• Device Catalogue Number: HARH23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE