MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL TRIO 3MM CURVE TIP 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ETRIO335H
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.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 a setup for a urology procedure the staff noticed that the blister pack was already opened and they were concerned about the sterility.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/15/2021.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 returned with returned outside its original packaging and the packaging was not returned.In addition, the device was returned with no apparent damage.Due to the device packaging not being returned, we are unable to investigate further on the reported packaging integrity.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL TRIO 3MM CURVE TIP 35CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11833840
• Report Number: 3005075853-2021-02743
• Device Sequence Number: 3172960
• Product Code: GEI
• UDI-Device Identifier: 10705036000297
• UDI-Public: 10705036000297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072177
• 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): 04/22/2021

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: 01/31/2023
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR