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

Model Number CD001

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: lap.Cholecystectomy.After retrieve the gallbladder, they found a part of a plastic in the patient.Everything was found and all parts are together for return the product.Additional information received from applied medical representative via email on 17aug2020: the customer has confirmed that the plastic part is part of the device.It's a green/blue plastic part.The customer did not give any further details as to its shape.Patient status: ok.Type of intervention: retrieval of separated part.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering observed that a portion of the tissue bad had fragmented.The cord loop was cut cleanly, which indicates that it was cut by an instrument.Based on the condition of the returned unit, it is likely that the tissue bag and cord loop were cut by an instrument, which caused the tissue bag to fragment.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: lap.Cholecystectomy.After retrieve the gallblader, they found a part of a plastic in the patient.Everything was found and all parts are together for return the product.Additional information received from applied medical representative via email on 17aug2020: the customer has confirmed that the plastic part is part of the device.It's a green/blue plastic part.The customer did not give any further details as to its shape.Patient status: ok.Type of intervention: retrieval of separated part.

• 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
• MDR Report Key: 10434896
• MDR Text Key: 204376129
• Report Number: 2027111-2020-00532
• Device Sequence Number: 1
• Product Code: GJC
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230407(30)01(10)1386855
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1386855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1