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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CTB03
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2019
Event Type  malfunction  
Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
 
Event Description
Procedure performed: lap appy.Event description: rep was not in the case.Limited information is available as the case took place in (b)(6) 2019.Trocar malfunctioned.Blade did not retract through the fascia like it was supposed to.The blade remained exposed after insertion.The trocar was removed.There was no patient injury.The device is expected to be returned.Intervention: device was removed.Patient status: no patient injury.
 
Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed.The event unit met current specification and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.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: lap appy.Event description: rep was not in the case.Limited information is available as the case took place in (b)(6) 2019.Trocar malfunctioned.Blade did not retract through the fascia like it was supposed to.The blade remained exposed after insertion.The trocar was removed.There was no patient injury.The device is expected to be returned.Intervention: device was removed.Patient status: no patient injury.
 
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Brand Name
CTB03, 5X100 KII SH BLD ZTHR 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 Key9720500
MDR Text Key180127508
Report Number2027111-2020-00364
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K072674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCTB03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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