MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 0 S/A CT LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number W9236T

Device Problem Break (1069)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

(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.The following information was requested, but unavailable: did this issue contribute to any patient adverse event? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

Event Description

It was reported that the patient underwent a laparoscopic complex intestinal adhesiolysis combined with small intestine alignment surgery on (b)(6) 2024 and suture was used.At 17:20, the patient underwent surgery.At the end of the surgery, the doctor closed the abdominal cavity.When the doctor sutured the peritoneum and fascia layer, the needle broke.The doctor immediately searched for the broken needle, and after double checking, it was confirmed that the broken needle was intact.The doctor replaced the needle and sutured it again.No patient consequence was reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 4/23/2024.Additional information: h6 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.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 60IN 0 S/A CT LP
• Type of Device: 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: 19002727
• MDR Text Key: 339060079
• Report Number: 2210968-2024-03632
• Device Sequence Number: 1
• Product Code: NEW
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W9236T
• Device Lot Number: TCMHCC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 21 YR
• Patient Sex: Male