MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 5-0 D/A RB-2; SUTURE, SURGICAL, ABSORBABLE

Model Number Z148H

Device Problem Material Separation (1562)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, it was reported that the problem of pulling off suture needle happened in surgery.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.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.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.The following information was requested, but unavailable: could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information: contacted with the sales rep today via phone and the information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 4/3/2023.Additional information: h6.The following additional information was received: the patient with unknown gender and age underwent thoracoscopic surgery for thoracic esophageal fistula.The operator used the z148h for esophageal sewing in a continuous suturing.The needle pull off and fell into the patient's body.The operator immediately gave the patient intraoperative imaging examination (with unknown specific examination method) to assist in looking for the needle and find it.After removal, the integrity of the needle was checked.After confirming that there was no residual foreign body, a new suture (with unknown specific product information) was replaced to continue the suture.The subsequent surgical operation went smoothly.There was no harm to the patient other than an unknown delay in surgery as a result of this event.No subsequent adverse events were reported.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.

• Brand Name: PDSII VIO 30IN 5-0 D/A RB-2
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16390831
• MDR Text Key: 309989808
• Report Number: 2210968-2023-01199
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031060272
• UDI-Public: 10705031060272
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: Z148H
• Device Catalogue Number: Z148H
• Device Lot Number: MKM573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1