MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C6001, 5MMX33CM PROBVALV DB, G2EB, 12B; SYSTEM, EVACUATOR, FLUID

Model Number	C6001
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: ni.During procedure, suction handpiece tip blocked with a metal piece and it came off when they started suctioning.This happened in 2 cases (second complaint to come, back to back surgeries).Intervention: ni.Patient status: patient is fine, and completely unaffected.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and applied medical was unable to confirm or replicate the complainant¿s experience.In the absence of the event unit, applied medical is unable to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the nature of the failure and the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: ni.During procedure, suction handpiece tip blocked with a metal piece and it came off when they started suctioning.This happened in 2 cases (second complaint to come, back to back surgeries).From the lap appendix kits.See photos.Additional photos available- see attachments.Additional information received via email from [name] 13.04.2021: i really only know as much as was written on the device box.I believe they took a new suction irrigation ( not applied medical) from the store room to complete the case.There are no pictures about the metal piece i only know what was written on device packet.The surgeon is extremely difficult to get hold of and i do not know the staff who were working.Intervention: ni.Patient status: patient is fine, and completely unaffected.

• Brand Name: C6001, 5MMX33CM PROBVALV DB, G2EB, 12B
• Common Device Name: SYSTEM, EVACUATOR, FLUID
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11674986
• Report Number: 2027111-2021-00455
• Device Sequence Number: 2998981
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)230113(30)01(10)1378987
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: C6001
• Device Catalogue Number: 101471627
• Device Lot Number: 1378987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1