MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; GCJ

Model Number CD003

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided 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

Lap chol - "after deploying strings were broken.Unfortunately no more information than this." additional information received via email from applied medical team member, december 14, 2016: after deploying and turning the bag 3 times clockwise the bag spontaneously fell of the arms.Patient status - no patient injury.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering determined that the deployment mechanism was deformed, indicating that the ratchet mechanism was overridden.The likely root cause of the customer's experience is use error, as retracting the unit prior to full deployment may cause damage to the deployment mechanism and cause the bag to fall off of the supports when fully deployed.The instructions for use (ifu) instruct the user to "hold the inzii retrieval system in an upright position and push the thumb ring forward to deploy and advance the rim of the bag into the body cavity.The thumb ring must be pushed completely forward until it has reached its advancing endpoint, which is indicated by a stop." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary, to ensure the performance and safety of its products.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.

Event Description

Additional information received via email from applied medical team member, (b)(6) 2017: "i had talked to the team at the time and she visited the operating room for this cer the bag fell of the prongs.".

• Brand Name: CD003, 5MM RETRIEVAL SYSTEM, 10/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: 6216597
• MDR Text Key: 63692629
• Report Number: 2027111-2016-00930
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)190824(30)01(10)1277369
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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: 08/24/2019
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1277369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1