MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; GCJ

Model Number CD001

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Procedure performed: laparoscopic cholecystectomy.The retrieval system did not work during a laparoscopic procedure.The first one did not deploy the bag.The second one did not have a bag to deploy.Patient status: no patient injury.Type of intervention: unknown.

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation.The introducer rod was returned without a tissue bag and cord loop.Upon inspection of the incident device, the tip of the pawl was observed to be deformed which suggests that it is likely the actuator was deployed/retracted more than once.Based on the condition of the unit that was returned, the exact root cause of the reported event could not be determined.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.

Event Description

Procedure performed: laparoscopic cholecystectomy.The retrieval system did not work during a laparoscopic procedure.The first one did not deploy the bag.The second one did not have a bag to deploy.Patient status: no patient injury.Type of intervention: unknown.

• Brand Name: CD001, 10MM RETRIEVAL SYSTEM, 10/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7940380
• MDR Text Key: 123534733
• Report Number: 2027111-2018-00373
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)210510(30)01(10)1325146
• Combination Product (y/n): N
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1325146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1