MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER USA - ENDOSCOPIC APPLICATOR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	3123SPEA
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.Attempts have been 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: what is the lot number? =>tlbhau.Where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?)=>inside the sterile barrier.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 a patient underwent an unknown procedure on (b)(6) 2024 and absorbable hemostat was used.When a nurse opened the package, it found that there was a hair in the package.Patient, doctors, and nurses all wear caps, so it is very likely that the hair was not from someone in the operating room.Another product was used.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
H6.Component code: g07002 ¿ no conclusion.Investigation summary: the product was returned to ethicon for evaluation.One endoscopic applicator inside its opened packaging for product code 3123spea.Upon visual inspection, the sample was passed through a white light to review the complete device and no foreign matter was observed.The endoscopic applicator was removed from the packaging and no anomalies were found.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 quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances related to the reported complaint condition 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h 6.Investigation findings: c22 ¿ photo investigation.Photo investigation summary this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an endoscopic applicator inside its open packaging for product code 3123spea, foreign matter can be seen in the image.Based on the tangible sample review from follow-up 1, the event described foreign matter inside sterile barrier is not confirmed.Please refer to the physical device analysis for further details.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 POWDER USA - ENDOSCOPIC APPLICATOR
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19982386
• Report Number: 2210968-2024-08499
• Device Sequence Number: 2760820
• Product Code: LMG
• UDI-Device Identifier: 10705031237513
• UDI-Public: (01)10705031237513(17)280930(10)TLBHAU
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/12/2024

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: 3123SPEA
• Device Lot Number: TLBHAU
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/09/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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