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

Model Number HARH23

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u93l3f.Additional information was requested and the following was obtained: did the damage to the package compromised the sterility of the device? yes.Investigation summary: the analysis results found that the harh23 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.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 surgery, before it was used on the patient, the package was found damaged.Changed to another device to complete the surgery.There was no patient consequence reported.No additional information can be provided.

• 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 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10521656
• MDR Text Key: 206527681
• Report Number: 3005075853-2020-04615
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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
• Device Lot Number: U93L3F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE