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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CFF33
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The event unit was returned to applied medical for evaluation. Visual inspection confirmed the complainant¿s experience of a damaged obturator tip. The tip of the obturator was fractured; however, the fragment was not returned for evaluation. Based on the condition of the returned unit, it is likely that the obturator tip contained a material abnormality, which could have made it more susceptible to damage. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level. A bent obturator tip is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury. However, the event is reportable due to the fractured obturator tip that was observed during the evaluation of the returned unit.

 
Event Description

Procedure performed: unknown. Event description: event date is unknown. Limited information was available at the time of the event. The trocar packaging was opened and it was noted that the obturator was bent. Another cff33 was opened and used in the case. There was no patient contact. Photos are not available. The device is available to be returned. Intervention: opened a new trocar to use in the case. Patient status: this incident was not patient related.

 
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Brand NameCFF33, 11X100 KII FIOS ADVFIX 6/BX
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key10535884
MDR Text Key212739559
Report Number2027111-2020-00559
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCFF33
Device Catalogue Number101245701
Device LOT Number1376559
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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