MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPIC, GENERAL PLASTIC SURGERY

Model Number CD004

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Event Description

Procedure performed: ni.Event description: during surgery, when the bag was in the abdomen, the resident was able to open the bag, & place the specimen in it.When he went to deploy the string, it fell apart.Additional information was received via email on 13-oct-2022 from [name], interim or supply chain manager, [nstitution].Unknown name of procedure and unknown concomitant devices.There was no patient injury.It is unknown if the bag broke or if there was any spillage."these are all the details i was given: during surgery, when the bag was in the abdomen, the resident was able to open the bag & place the specimen in it.When he went to deploy the string, it fell apart.X ray taken & cleared of foreign object in patient's abdomen by dr.[name] at 12:04." patient status: no patient injury was reported within the description of the event.Intervention: "x-ray taken & cleared of foreign object in patient's abdomen.".

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow up report will be provided following the conclusion of the investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.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.

Event Description

Procedure performed: unknown.Event description: during surgery, when the bag was in the abdomen, the resident was able to open the bag, & place the specimen in it.When he went to deploy the string, it fell apart.Additional information was received via email on 13oct2022 from [name], interim or supply chain manager, [nstitution].Unknown name of procedure and unknown concomitant devices.There was no patient injury.It is unknown if the bag broke or if there was any spillage."these are all the details i was given: during surgery, when the bag was in the abdomen, the resident was able to open the bag, & place the specimen in it.When he went to deploy the string, it fell apart.X ray taken & cleared of foreign object in patient's abdomen by dr.[name] at 12:04." patient status: no patient injury was reported within the description of the event.Intervention: "x ray taken & cleared of foreign object in patient's abdomen.".

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX
• Type of Device: LAPAROSCOPIC, 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: 15663294
• MDR Text Key: 302489022
• Report Number: 2027111-2022-00785
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)240929(30)01(10)1430022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060051
• 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: 12/01/2022

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: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1430022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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