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

Model Number CD001

Device Problem Component Missing (2306)

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

Event Date 04/14/2021

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

Type of procedure performed: laparoscopic cholecystectomy.Rep was not present for the case.When the surgeon deployed the device inside the patient there was no bag.There was no patient injury, the patient is fine.The case was completed with a new cd001 without issue.Product available for return.Photos are available.Patient status: no patient injury.Type of intervention: the case was completed with a new cd001 from a different box.

Event Description

Type of procedure performed: laparoscopic cholecystectomy.Rep was not present for the case.When the surgeon deployed the device inside the patient there was no bag.There was no patient injury, the patient is fine.The case was completed with a new cd001 without issue.Product available for return.Photos are available.Additional information was received via email on 26apr2021 from [name]: "there was one attempt in advancing the plunger when they saw there was no bag.The prongs were of course inside the body once the plunger actuated as if it were pushing a bag through." patient status: no patient injury.Type of intervention: the case was completed with a new cd001 from a different box.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the tissue bag was missing from the returned unit.Applied medical is unable to determine whether the unit was distributed without the tissue bag 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.

• 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: 11729638
• MDR Text Key: 249672582
• Report Number: 2027111-2021-00466
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)231021(30)01(10)1399845
• 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: 07/13/2021

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: 10/21/2023
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1399845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APPLIED MEDICAL TROCAR