MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z310H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body In Patient (2687)
Date of Event	01/26/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported by an attorney that a patient underwent a partial nephrectomy with a robot procedure on (b)(6) 2024 and suture was used.The thread that had a needle at the beginning of the procedure was removed by a gripper of the robot and at the exit of the trocar by the operative aid, the needle had disappeared (only the thread was removed).The surgeon was immediately notified of this incident.Staff immediately searched for the needle in the operative cavity using a camera and then an image intensifier, but the needle was not found.Staff believe that the needle has remained in the operating cavity.The postoperative period was unfortunately complicated by cardiopulmonary arrest.Resuscitation, with adrenaline injected, without external electric shock, was initiated and performed for 20 minutes.Cardio-respiratory rhythm did not recover, decision to stop resuscitation in multidisciplinary consultation, and death of the patient.Patient deceased.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.H6 component code: g07002 device not returned.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 h6 - type of investigation.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18859514
• Report Number: 2210968-2024-02664
• Device Sequence Number: 18232731
• Product Code: NEW
• UDI-Device Identifier: 10705031060418
• UDI-Public: 10705031060418
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Z310H
• Device Lot Number: THMJHT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown