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

Model Number CA090

Device Problems Failure To Adhere Or Bond (1031); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the 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

Lap.Gastric bypass - "second clip placement did not seem placed on the ductus.Dr says he felt the resistance when placing but closed clip fell into patient.Rep and (b)(6) where witnessing case but could not see what happened.Later on in procedure one clip fell out of instrument a ter placing clip - open." patient status - ok.

Manufacturer Narrative

On march 18, 2016, applied medical issued a voluntary class ii recall of the ca090 direct drive clip applier due to increased customer feedback indicating inconsistent clip application, which has the potential to lead to unoccluded vessels.An internal corrective and preventative action (capa) has been initiated to conduct a thorough investigation and implement appropriate corrective actions.Fda has issued recall number z-1621-2016 for this recall.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 Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5549209
• MDR Text Key: 41939677
• Report Number: 2027111-2016-00269
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)190112(30)01(10)1263340
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/12/2019
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1263340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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