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

Model Number CD001

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the device was being used "when wanted to deploy for specimen retrieval." the "guiding bead does not goes with the bag and stuck in the entrance fo the shaft as per photo." no clinical impact to the patient as a result of the event."as the bag already deploed , the bag are tighten with the string available." product is not available for return.Additional information was received via email on (b)(6) 2023 from [name], territory manager - singapore, applied medical.Yes, the guide bead detached from the bag.There was no damage to the bag.The guide bead detached from the cord.The cord was not damaged.The bead component separated outside of the patient.Intervention: "as the bag already deploed, the bag are tighten with the string available." patient status: no clinical impact to the patient as a result of the event.

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: the device was being used "when wanted to deploy for specimen retrieval." the "guiding bead does not goes with the bag and stuck in the entrance fo the shaft as per photo." no clinical impact to the patient as a result of the event."as the bag already deploed , the bag are tighten with the string available." product is not available for return.Additional information was received via email on 04apr2023 from [name], territory manager - singapore, applied medical yes, the guide bead detached from the bag.There was no damage to the bag.The guide bead detached from the cord.The cord was not damaged.The bead component separated outside of the patient.Intervention: "as the bag already deploed, the bag are tighten with the string available." patient status: no clinical impact to the patient as a result of the event.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided by the user facility, confirming the complainant's experience of bead detachment.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause 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.

• 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: 16818288
• MDR Text Key: 314041029
• Report Number: 2027111-2023-00427
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)240801(30)01(10)1424748
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 100864401
• Device Lot Number: 1424748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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