MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN BLADE MOD 4.0IN; E-Z CLEAN BLADE MODIFIED 4.0 INCH

Model Number	0014AM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the modified tip part departed too easily during cleaning with the tip cleaner.The tip disappeared intra-op, the nurse and surgeon tried to find it.Finally they found it, but it made too much time wasted (op was delayed for 30mins).
Additional Manufacturer Narrative
(b)(4) date sent: 6/1/2023, only event year known: 2023.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.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/10/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0014am device was returned with the ptfe insulation detached and returned.In addition, the coating of the tip electrode was damaged.The tip was not detached as reported, therefore, the reported event was not confirmed.The electrode was tested for continuity and passed the test.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No definitive root cause could be reached that might have caused the detachment of the ptfe.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/13/2023.Photo anlaysis: this is an analysis of an image submitted for evaluation.Image: the image provided by the customer shows an electrode tip with the blue sheath detached.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device batch sbmdmx, and no non-conformances were identified.

• Brand Name: E-Z CLEAN BLADE MOD 4.0IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 4.0 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 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: 17037428
• Report Number: 3005075853-2023-03639
• Device Sequence Number: 12376770
• Product Code: GEI
• UDI-Device Identifier: 10614559100165
• UDI-Public: 10614559100165
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081791
• 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,Followup
• Report Date (Section B): 08/10/2023

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: 0014AM
• Device Catalogue Number: 0014AM
• Device Lot Number: SBMDMX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 08/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 06/13/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown