MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 17CM PLUS ADAPTIVE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR17F
Medical Device Problem Codes	Delivered as Unsterile Product (1421); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/22/2024 b3: event year only reported: 2024 d4 batch #: unknown additional information was requested and the following was obtained: does the damage to the package compromise the sterility of the device? - the clinic cannot say for sure that sterility is compromised, but it has reason to believe so because there are creases on the paper part of the packaging.Was the device used on a patient? if so, was there any patient consequence? - the instruments were placed in a quarantine storage area upon receipt, were not and will not be used.How was the product purchased? is there an indication of how the product was distributed? - the purchase of medical products was carried out through the state procurement portal is there any indication of the source? - no based on the packaging, is there any indication of which the original genuine product may have come from? - no an analysis of the product could not be performed since a physical sample was not received for evaluation.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 that the supplier delivered medical products to the clinic in primary packaging without secondary cardboard.The primary packaging has signs of creasing, there is a suspicion of a violation of the sterility of the medical product.It was discovered that these medical products were purchased through parallel import.The purchase of medical products was carried out through the state procurement portal.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2024.This is an analysis of an image submitted for evaluation.Image 1: the photo shows a package label of product code har17f, lot # 733c62, and expiration date: 2028-10-31.The lot number was reviewed, and it belongs to a har17f device.Based on the lot trace performed, this product/lot was not approved to be sold in the region of this file complaint, therefore a confirmed diversion is confirmed.A manufacturing record evaluation was performed for the finished device lot number 733c62, and no non-conformances were identified.

• Brand Name: HS FOCUS 17CM PLUS ADAPTIVE
• Common Device Name: 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: 20762510
• Report Number: 3005075853-2024-08952
• Device Sequence Number: 8671735
• Product Code: LFL
• UDI-Device Identifier: 10705036014737
• UDI-Public: (01)10705036014737(17)281031(10)733C62
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K132612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: HAR17F
• Device Lot Number: 733C62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HAND PIECE
• Patient Sex: Unknown