MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the tissue bag and cord loop.Visual inspection confirmed that the guide bead was stuck inside the shaft.Engineering removed the guide bead and was unable to re-insert the guide bead back into the shaft to replicate the complainant¿s experience.All components were measured and were within specifications.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause based on the evaluation of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report reflects the combined initial and final report.

Event Description

Type of procedure performed: ni.Ring of the guide bead got stuck/slipped into the shaft so the bag could not be closed.Update received from applied medical representative via email on 02nov2020: i tried to find this out, but no information so far.Very difficult because of corona.I cannot visit the operating room in [name] to ask and find out more.Patient status: ni.Type of intervention: ni.

• Brand Name: CD001, 10MM RETRIEVAL SYSTEM, 10/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 11335738
• MDR Text Key: 266043439
• Report Number: 2027111-2021-00336
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230508(30)01(10)1387517
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060051
• 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
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1387517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• 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