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

Model Number	801407
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
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 physician reported "dirt" was found on a surgical pattie (id: 801407) when it was opened during the procedure prior to patient use.The procedure was completed with a replacement product available.No surgical delay.
Additional Manufacturer Narrative
Surgical pattie (id 801407) 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 - complaint of burn mark on pattie confirmed, brown spot present on green string.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 pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie 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 pattie 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.Operators identified in the traveler will be retrained per an ils.What perceived to be "dirt found in the product" was actually a burn mark that happened during the manufacturing process.Therefore the complaint condition is confirmed.Root cause confirmed, per the failure analyst.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.A corrective and preventive action was implemented to minimize the issues above.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15716811
• Report Number: 3014334038-2022-00246
• Device Sequence Number: 12431093
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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 Model Number: 801407
• Device Catalogue Number: 801407
• Device Lot Number: 6229504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2022
• 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