MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD003

Device Problem Component Missing (2306)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Procedure performed: operative laparoscopy left ectopic.Event description: "no bag.Came empty" the product was used during the procedure.There was no harm to the patient.The case was able to be completed.Product is available for return.Additional information was received via email on 05aug2022 from [name] purchasing contract manager [hospital] it is unknown what other instruments were being used at the time of the event.Another device was used to complete the case.There was no bag, the prongs came out and were exposed inside the patient.Patient status: no patient injury.Type of intervention: the case was completed with a new device.

Manufacturer Narrative

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

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a missing bag.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the 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.

Event Description

Type of procedure: operative laparoscopy left ectopic.Event description: "no bag.Came empty" the product was used during the procedure.There was no harm to the patient.The case was able to be completed.Product is available for return.Additional information was received via email on 05aug2022 from [name] purchasing contract manager [institution] it is unknown what other instruments were being used at the time of the event.Another device was used to complete the case.There was no bag, the prongs came out and were exposed inside the patient.Patient status: no patient injury.Type of intervention: the case was completed with a new device.

• Brand Name: CD003, 5MM 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: 15272261
• MDR Text Key: 302285282
• Report Number: 2027111-2022-00709
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)250518(30)01(10)1451643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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 Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1451643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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