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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL CA090, DIRECT DRIVE LCA 3/BX; FZP

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APPLIED MEDICAL CA090, DIRECT DRIVE LCA 3/BX; FZP Back to Search Results
Model Number CA090
Device Problem Bent (1059)
Patient Problem No Information (3190)
Event Date 10/20/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4) ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
 
Event Description
Laparoscopic cholecystectomy - "attempting to use clip applier and clips continuously slid halfway off.Disclaimer: surgeon became upset and bent, 1 clip applier." patient status "unknown.".
 
Manufacturer Narrative
Investigation summary: one event unit was returned for evaluation.Upon inspection, engineering actuated the unit from lot 1249462, all clips loaded properly; however, one clip did not close properly.The unit was disassembled, engineering found the jaw component was too wide.The root cause of the customer's experience was likely due to the wide jaw component which may lead to incomplete clip closure.On march 18, 2016, applied medical issued a voluntary recall of the ca090 direct drive® clip applier due to increased customer feedback indicating inconsistent clip application.Although malformed clips are typically readily apparent to the user, this failure mode may lead to unoccluded vessels.We regret this disruption in supply, yet believe that this is in the best interest of our customers.Additional information was requested and provided.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
 
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Brand Name
CA090, DIRECT DRIVE LCA 3/BX
Type of Device
FZP
Manufacturer (Section D)
APPLIED MEDICAL
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer (Section G)
APPLIED MEDICAL
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
22872 avenida empresa
rancho santa margarita, CA 92688
9497138233
MDR Report Key5227158
MDR Text Key31519162
Report Number2027111-2015-00788
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/20/2015
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 Other
Device Expiration Date06/25/2018
Device Model NumberCA090
Device Catalogue Number101416101
Device Lot Number1249462
Other Device ID Number00607915117306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/20/2015
Initial Date FDA Received11/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1621-2016
Patient Sequence Number1
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