MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN SURG STRIP2X6-200; SURGICAL STRIPS

Catalog Number	801455
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a particle was visible in a surgical strip (id 801455).Issue detected prior to patient use.The procedure was completed with a replacement product available.No patient injury, no surgical delay.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The surgical strip was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a small brown spot was found to be present on the face of the strip.The spot is located in the cottonoid material and not on the welded portion of the strip.This indicates discoloration during the cottonoid production process.Root cause - the complaint can be confirmed.Cottonoid is produced in a process that involves shredding rayon, needling it into large sheets, and saturation the material in a binder solution.The saturated material is then fed through an oven to dry and cure the cottonoid.During this process, binder can built up on rollers in the oven resulting in burned binder and discoloration on the sheet of cottonoid.During the strips process, the strip is visually inspected by the operator for signs of defects including discoloration.In this instance, the operator did not properly inspect the strip.The applicable operators will be retrained to properly inspect for discoloration.

• Brand Name: CODMAN SURG STRIP2X6-200
• Common Device Name: SURGICAL STRIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18292043
• Report Number: 3014334038-2023-00186
• Device Sequence Number: 20507275
• Product Code: HBA
• UDI-Device Identifier: 10381780515111
• UDI-Public: 10381780515111
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 801455
• Device Lot Number: 6561233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown