MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 3INX4IN; BARRIER, ABSORBABLE, ADHESION

Catalog Number	4350
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional 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.Additional information was requested and the following response was provided: please describe the type of foreign matter that was observed.Could not confirm, according to feedback, when operator open the product, there was an unknown object falling down on the floor, the product was not used and will be returned for investigation, but foreign matter (unknown object) was not retrieved from floor.Are there any photos of the foreign matter available? no.H3 analysis summary: the product was returned to ethicon for evaluation.One open sample was received for analysis that belong to product code 4350.In addition, a photo was provided showing the same conditions of the product received.During visual inspection of the returned sample, no foreign matter could be observed inside the packaging or in the gynecare interceed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that it was found that there was foreign object on the product when preparing for surgery.When operator open the product, there was an unknown object falling down on the floor, the product was not used and foreign matter (unknown object) was not retrieved from floor.Changed to another one to complete the surgery.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20268006
• Report Number: 2210968-2024-10102
• Device Sequence Number: 20643018
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: (01)10705031005396(17)280531(10)TLE5351
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: 4350
• Device Lot Number: TLE5351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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
• Patient Sex: Unknown