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

Model Number CD004

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Name of procedure being performed: nephrectomy.Detailed description of event: this is a complaint from the market.Administrative no.C19234759.Please refer to the complaint sheet for investigation.Hospital: (b)(4).Subject of complaint: "only the support wire came out".Report from the sales rep: "only the support wire came out with the bag staying in the sheath during the procedure.The case was completed with the new one." the additional information is as follows: regarding if the bag didn't unroll/unravel fully, only the support wire came out with the bag staying in the sheath.The metal supports were fully exposed upon deployment.Per the component list, the original packaging and the introducer are expected to return.Additional information was received from quality assurance engineer, via e-mail on february 13th, 2020: during the visual inspection, the bag didn't seem to be remained in the sheath.It is unknown how the device was safely removed from the patient.Regarding the statement "it was confirmed there was not enough room", it's been confirmed that it means that "there was not enough room in the body cavity for the bag to open." patient status: "no patient injury".Type of intervention: "the case was completed with the new one.".

Event Description

Name of procedure being performed: nephrectomy.Detailed description of event: this is a complaint from the market.Administrative no.(b)(6).Please refer to the complaint sheet for investigation.Hospital: (b)(6) hospital.Subject of complaint: "only the support wire came out." report from the sales rep: "only the support wire came out with the bag staying in the sheath during the procedure.The case was completed with the new one." the additional information is as follows: regarding if the bag didn't unroll/unravel fully, only the support wire came out with the bag staying in the sheath.The metal supports were fully exposed upon deployment.Per the component list, the original packaging and the introducer are expected to return.Additional information was received from quality assurance engineer, via e-mail on february 13th, 2020: during the visual inspection, the bag didn't seem to be remained in the sheath.It is unknown how the device was safely removed from the patient.Regarding the statement "it was confirmed there was not enough room", it's been confirmed that it means that "there was not enough room in the body cavity for the bag to open." patient status: "no patient injury." type of intervention: "the case was completed with the new one.".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the tissue bag.Engineering was unable to confirm that the tissue bag was not deployed as the tissue bag was not returned with the event unit.Applied medical has reviewed the details surrounding the event and the returned unit and is unable to determine the 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: 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
• MDR Report Key: 9742427
• MDR Text Key: 180527011
• Report Number: 2027111-2020-00374
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915126773
• UDI-Public: (01)00607915126773(17)220604(30)01(10)1359478
• Combination Product (y/n): N
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

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: 06/04/2022
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Device Lot Number: 1359478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1