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

Model Number CD001

Device Problems Material Fragmentation (1261); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

Name of procedure being performed: robot assisted lap prostatectomie.Detailed description of event: when closing the bag, the green bead pops into the shaft.Not possible to retrieve the instrument out of the patient.Patient status: no patient injury.

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: robot assisted lap prostatectomie.Detailed description of event: when closing the bag, the green bead pops into the shaft.Not possible to retrieve the instrument out of the patient.Additional information received from applied medical representative via email on 14-apr-2022: the surgical staff sometimes intentionally break the actuator at the point where the cord is attached (more users do this).It is not known if this was also done during this procedure.But if it was, it is not part of the complaint.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, without the bag, the cord loop and the bead.Visual inspection confirmed the complainant¿s experience of the bead going back inside the tube as scrapes were observed on the distal end of the tube.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the exact root cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: update device code in h6.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13674313
• MDR Text Key: 289869066
• Report Number: 2027111-2022-00439
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)241124(30)01(10)1437470
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1437470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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