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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF05, 5X75 KII FIOS ADV FIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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APPLIED MEDICAL RESOURCES CFF05, 5X75 KII FIOS ADV FIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CFF05
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
 
Event Description
Procedure performed: unknown.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.The breakage of the obturator.Report from the sales rep: the tip of the obturator was damaged while puncturing with the optical method.The fragments may have fallen into the body and was removed with an intraperitoneal lavage.Body fluid entered the inside of the obturator during the insertion.The doctor may have pressed the camera considerably and inserted the optical insertion.Initial investigation report: the event unit was returned to us and visually inspected.The tip of the obturator was fragmented.The fragment was not returned.The unit will be returned to amr for further evaluation.Intervention: the fragments may have fallen into the body and was removed with an intraperitoneal lavage.Patient status: no patient injury.
 
Event Description
Procedure performed: unknown.Event description: this is a complaint from the market.Please refer to the complaint sheet for investigation.The breakage of the obturator.Report from the sales rep: the tip of the obturator was damaged while puncturing with the optical method.The fragments may have fallen into the body and was removed with an intraperitoneal lavage.Body fluid entered the inside of the obturator during the insertion.The doctor may have pressed the camera considerably and inserted the optical insertion.Initial investigation report: the event unit was returned to us and visually inspected.The tip of the obturator was fragmented.The fragment was not returned.The unit will be returned to amr for further evaluation.Intervention: the fragments may have fallen into the body and was removed with an intraperitoneal lavage.Patient status: no patient injury.
 
Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a damaged obturator tip.The clear fragment was identified as a part of the obturator tip.Based on the condition of the returned unit and the description of the event, it is likely that the obturator tip was damaged due to forces that were exerted on the tip during the procedure.It is also possible that lipid exposure and/or a material abnormality could have made the unit 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.
 
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Brand Name
CFF05, 5X75 KII FIOS ADV FIX 6/BX
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key10363060
MDR Text Key201774619
Report Number2027111-2020-00520
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K083638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 10/26/2020
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 Model NumberCFF05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received07/28/2020
Supplement Dates FDA Received10/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CAMERA
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