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

Catalog Number HARH36

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r94k09.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.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 product is 100% inspected prior to release.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the package was damaged and there was a concern about the sterility of the product.There were no patient consequences reported.

• Brand Name: HARMONIC ACE PLUS 7 W ADV HEMOSTASIS
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8416583
• MDR Text Key: 138933126
• Report Number: 3005075853-2019-17207
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: HARH36
• Device Lot Number: R94K09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1