MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*5MM CRVD DISSECTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 5DCD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 7/26/2023.D4: batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: were there any patient consequences? if yes, please describe.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.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.

Event Description

It was reported that during an unknown procedure, the device jaws were not engaged and were open.

Manufacturer Narrative

(b)(4).Date sent: 9/21/2023.D4: batch # unk.Additional information was requested and the following was obtained: "the patient has no problems." investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the 5dcd instrument was returned inside it's packaging opened with no damage in the external components.The instrument was tested and functioned properly as it did open and closed without any difficulties noted.The end effectors were inspected and no damaged were noted.Although no conclusion could be reached on the cause of the reported event.The event described could not be confirmed as the instrument performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the instrument that could not be replicated during the laboratory analysis.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 8/28/2023.D4: batch # unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17398242
• MDR Text Key: 320158883
• Report Number: 3005075853-2023-05320
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036000778
• UDI-Public: 10705036000778
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K984240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5DCD
• Device Lot Number: 260C62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1