MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 STRAIGHT 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLX137S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: x95u6u.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the upper jaw broken at the closure slot.All pieces were returned with the device.In addition the cable was cut off.No functional testing could be performed with the generator.The jaws could not close fully.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances related to the reported complaint condition were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.
Event or Problem Description
It was reported that during an unknown procedure the jaws on the device was stuck in the open position.Surgeon had to remove the trocar in order to remove the device.After a five minute delay the case was completed with no patient consequences.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16094796
• Report Number: 3005075853-2023-00024
• Device Sequence Number: 15082135
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• 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
• Report Date (Section B): 01/04/2023

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 Model Number: NSLX137S
• Device Catalogue Number: NSLX137S
• Device Lot Number: X95U6U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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