MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	2082
Medical Device Problem Codes	Material Discolored (1170); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts are being 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.Additional information was requested, and the following was obtained: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) inside the sterile barrier.Is it possible that the foreign material fell into packaging upon opening of device? no.Was the product seal on the foil still intact when the package was opened? yes.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 or Problem Description
It was reported that the patient underwent a thyroid and parathyroid resection procedure on an unknown date and absorbable hemostat was used.When the doctor was unpacking and preparing to use the product during the operation, doctor found black spots on the gauze and color difference, with the gauze turning yellow in color.Changed to another one to complete the surgery.No patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation?, h 3.Device evaluated by manufacturer? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - no device problem found.H 6.Investigation findings: c22 ¿ photo evaluation.H3 investigation summary: the product was returned to ethicon for evaluation.One open sample was received for analysis.Product code 2082.Additionally, four photos were provided, and it showed the same condition of the samples received.The visual assessment of the sample revealed dirt or dark stain on the folder and on the surgicel product, which appears to be unrelated to the manufacturing process.Also, surgicel product was noted to be as expected and no defect color on the surgicel could be observed during the evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch and no 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, 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.

• Brand Name: SURGICEL SNOW 2INX4IN(5.1CMX10.2CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23829161
• Report Number: 2210968-2025-14166
• Device Sequence Number: 15710986
• Product Code: LMG
• UDI-Device Identifier: 10705031063594
• UDI-Public: (01)10705031063594(17)270630(10)109QQ9
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 2082
• Device Lot Number: 109QQ9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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