MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 1/2X3 -200; SURGICAL PATTIES

Catalog Number	801407
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported "dirt" was found in a surgical patty (id 801407) when it was opened during a procedure prior to patient use.Therefore, another product was used to complete the procedure.There was less than 30 minutes of surgical delay in the procedure, and no adverse consequences was observed.According to information provided, it is unknown how and where the product was stored.
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.
Additional Manufacturer Narrative
The surgical patty (b)(4) was returned for evaluation.Device history record (dhr) ¿ there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a burn mark was observed on the face and rear of the pattie around the area of the green string.Root cause analysis - the complaint can be confirmed.A cottonoid material is formed from rayon.During processing, this rayon material is broken down into small, loose fibers.If the fibers do not break down properly, a small cluster of fibers can result.This creates a thick spot in the patty.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the patty and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each patty and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Applicable operators will be retrained to properly inspect for burns.
Event or Problem Description
N/a.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Common Device Name: SURGICAL PATTIES
• 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: 18291691
• Report Number: 3014334038-2023-00182
• Device Sequence Number: 6667648
• Product Code: HBA
• UDI-Device Identifier: 10381780515029
• UDI-Public: 10381780515029
• 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: Other
• 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: 801407
• Device Lot Number: 7122096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown