MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 700 SHEARS 45CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR745
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 1/24/2025 b3: event year only reported: 2025 d4 batch #: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported prior to an unknown procedure the white inner boxes the plastic is broke and air is being let in.At the time of the call it was unknown if the brown outer box was damaged.No patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2025 additional information was requested and the following was obtained: was the sterility of the device compromised due the damage? unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/25/2025.D4 batch #: y70212.Investigation summary- the product was returned 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 the quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch y70212, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/24/2025.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: HARMONIC 700 SHEARS 45CM
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21232761
• Report Number: 3005075853-2025-00638
• Device Sequence Number: 4287319
• Product Code: LFL
• UDI-Device Identifier: 10705036035787
• UDI-Public: (01)10705036035787(17)290430(10)Y70212
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K221790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HAR745
• Device Lot Number: Y70212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 02/17/2025; 02/24/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/13/2025; 02/24/2025; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown