MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC HYSTEROSCOPY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10556
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed due to a retrospective review of complaints.This complaint has been reopened for further investigation.A user facility medwatch report (#(b)(4)) was received reporting contaminated cmc hysteroscopy pack.After patient was asleep for surgical procedure, supply on the sterile field was contaminated from factory.Suction tubing contaminated with red substance on outside of tubing.All sterile supplies and instruments on the field had to be replaced.Suction tubing saved for quality.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
After patient was asleep for surgical procedure, supply on the sterile field was contaminated from factory.Suction tubing contaminated with red substance on outside of tubing.All sterile supplies and instruments on the field had to be replaced.Suction tubing saved for quality.(cmc hysteroscopy pack).
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the tubing supplier conmed.Potential root cause: raw material (resin) with foreign matter from conmed's supplier.The following corrective actions have taken place by conmed: requested an incoming inspection of the resin of 30 lots.The device history record (cips) for the resin part numbers will be updated in order to include the inspection of resin.Deroyal no longer receives this product from conmed.Quality control issued a memo which was reviewed with the supervisors and assembly personnel to be more aware of any debris, discoloring, colored /unknown substances, etc.On products.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CMC HYSTEROSCOPY PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 12258390
• Report Number: 3005011024-2021-00007
• Device Sequence Number: 20084096
• Product Code: LRO
• UDI-Device Identifier: 00749756364287
• UDI-Public: 00749756364287
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: No Information
• Device Model Number: 89-10556
• Device Catalogue Number: 89-10556
• Device Lot Number: 53218193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1