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

Model Number	SNGCB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.Medical device: 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.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, the blade came off when the device was connected to the handpiece.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/25/2022 investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was received with the curve blade out off the shaft sheath.The event reported is confirm.No functional test could be perform due to the condition of the device returned, the handles was disassembled to inspect the internal components and was noted that the insulated retention pin was missing and not retuned.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery quality system.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: HS SYNERGY CURVED BLADE
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13443628
• Report Number: 3005075853-2022-00640
• Device Sequence Number: 19915484
• Product Code: LFL
• UDI-Device Identifier: 10705036002802
• UDI-Public: 10705036002802
• Combination Product (Y/N): N
• PMA/510(K) Number: K012176
• 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): 02/03/2022

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: 11/30/2025
• Device Model Number: SNGCB
• Device Catalogue Number: SNGCB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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
• Patient Sex: Unknown