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

Model Number CD003

Device Problem Activation, Positioning or Separation Problem (2906)

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 - "system didnt work, no more information available.Please check." additional information received via email from applied medical team member, december 14, 2016: for this cer the bag fell off 3x in one procedure trying to place the gallbladder it looks like the problems all occurred in the same lot (as in cer) but they didn't save them all.Patient status - no patient injury.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation without the tissue bag.The cord loop was severed and frayed in multiple places.The actuator was found to be damaged.The exact root cause of the event could not be confirmed.The bag could have become detached from the prongs while being unrolled in the distal direction versus directly downward.However, it cannot be confirmed what method was used to unroll the bag or to place the specimen in the bag.The cord loop breakage observed is likely due to the interaction between the cord loop and the inner edge of the deployment tube.Applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of event to occur.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, then a supplemental report will be submitted to the fda.

• 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: 6216574
• MDR Text Key: 63691225
• Report Number: 2027111-2016-00928
• 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: 02/10/2017

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: 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
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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