MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number CFF33

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the event product was returned for evaluation.Engineering was able to confirm the customer's experience of the bent obturator tip.Upon closer inspection, engineering noted that the tip was fractured.The bends on the obturator shaft were created by the customer after usage of the product.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to the manufacturing of this lot.Although the root cause could not be confirmed, applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.This report represents the initial and final report.Based on the description of the obturator tip bending during initial intake of the complaint, the event was not reported as it was unlikely to cause or contribute to death or serious injury.After engineering performed their evaluation, the event is now deemed reportable.

Event Description

Laparoscopy for endometriosis - "the tip of the obturator bent while doctor was inserting the trocar into the abdomen.The doctor then bent the obturator in half - says not good quality anymore." patient status: "discharged." type of intervention: unknown.

• Brand Name: CFF33, 11X100 KII FIOS ADVFIX 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6215826
• MDR Text Key: 63654022
• Report Number: 2027111-2016-00919
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00060791511987
• UDI-Public: (01)00060791511987(17)181220(30)01(10)1260096
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2018
• Device Model Number: CFF33
• Device Catalogue Number: 101245701
• Device Lot Number: 1260096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1