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

Model Number C6001

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: SYSTEM, EVACUATOR, FLUID
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11674986
• MDR Text Key: 246053062
• Report Number: 2027111-2021-00455
• Device Sequence Number: 1
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)230113(30)01(10)1378987
• Combination Product (y/n): N
• PMA/PMN Number: K003443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1