MAUDE Adverse Event Report: APPLIED MEDICAL CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; GCJ

Model Number CD004

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

Robotic lap nephrectomy - "this was emailed from the surgeon who had the problem - "the string rip inside the pt as we are tightening it, so that the bag becomes dislodged inside the pt.When you pull out the hand piece and is rendored useless inside the patient." patient status: fine.

Manufacturer Narrative

The incident device 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.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation with the bag detached from the unit.Upon inspection, engineering found that the unit was fully deployed, the bag was cinched, and the cord loop had been cut.The exact root cause of the string breakage remains unknown.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As a part of this process, each cord loop goes through multiple stages of inspection during the assembly process.Although the root cause of the incident experience could not be determined, applied medical is currently researching possible device enhancement intended to further minimize the potential for this type of incident to occur.This document represents our final report.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 949713-823
• MDR Report Key: 4157357
• MDR Text Key: 4929319
• Report Number: 2027111-2014-00352
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2014,11/14/2014

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 Model Number: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1226222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2014
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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