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

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.

• 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 Key: 5227158
• MDR Text Key: 31519162
• Report Number: 2027111-2015-00788
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• 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 Date: 06/25/2018
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1249462
• Other Device ID Number: 00607915117306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1621-2016
• Patient Sequence Number: 1