MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY COMBO HOOK BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SNGHK2
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Additional information was requested and the following was obtained: did the issue with the packaging compromise the sterility of the device? that¿s what we are unsure of, it does appear that you can see light through the cracks of the packaging.For that reason, we wanted to call it and send it in as they are all coming from the same lot.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 during an unknown procedure, upon receipt of the device, they opened the box and the devices appeared to have "cracks" in the individual packaging that was allowing light to get through.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2020.Investigation summary: the device a was returned inside its sterile package.Upon visual inspection, it was noted that the tyvek had delamination.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique; however, no conclusion could be reached as to what may have caused this condition.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: HS SYNERGY COMBO HOOK BLADE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10534432
• Report Number: 3005075853-2020-04670
• Device Sequence Number: 1192548
• Product Code: LFL
• UDI-Device Identifier: 10705036013815
• UDI-Public: 10705036013815
• Combination Product (Y/N): N
• PMA/510(K) Number: SNGHK2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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 Expiration Date: 03/30/2021
• Device Model Number: SNGHK2
• Device Catalogue Number: SNGHK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 12/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE.; GENERATOR AND HANDPIECE.