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

Model Number CD004

Device Problem Material Rupture (1546)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Procedure performed: "xi hysterectomy with a right ooph-salpingectomy".Event description: the cd004 inzii bag ruptured when the surgeon put the right ovary in it.The bottom of the bag opened and spilled into the abdomen.The surgeon used a cd001 inzii bag and it broke inside the patient.The rep was not present for the case.Additional information will be provided.Product is available for return.Additional information was received via email on 22nov2022 from [name], account manager associate, applied medical."these were actually two separate cases, not 2 defective products in one case as initially said by me." the port size was not enlarged.The bag was saved to visualize where the break occurred.There were no fragments.The case was completed with "no issues"."patient okay for both" procedures.Patient status: "patient okay for both" procedures.Intervention: the case was completed with "no issues".

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: "xi hysterectomy with a right ooph-salpingectomy" event description: the cd004 inzii bag ruptured when the surgeon put the right ovary in it.The bottom of the bag opened and spilled into the abdomen.The surgeon used a cd001 inzii bag and it broke inside the patient.The rep was not present for the case.Additional information will be provided.Product is available for return.Additional information was received via email on 22nov2022 from [name], account manager associate, applied medical "these were actually two separate cases, not 2 defective products in one case as initially said by me." the port size was not enlarged.The bag was saved to visualize where the break occurred.There were no fragments.The case was completed with "no issues"."patient okay for both" procedures.Patient status: "patient okay for both" procedures.Intervention: the case was completed with "no issues".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, with a portion of the bag.The complainant¿s experience of damaged retrieval bag was confirmed as the bag portion returned had cuts and a hole.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the exact cause of the reported event based on the evaluation of the returned unit.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/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: 15905837
• MDR Text Key: 308031547
• Report Number: 2027111-2022-00842
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)250814(30)01(10)1464010
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: 1464010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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
• Treatment: "STANDARD ROBOT ARMS"