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

Model Number CD003

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: laparoscopy.The account manager was not present for the case.Limited information was provided when the account manager reached out for additional information regarding the event.The second inzii was deployed and it was being use to fish out uterine clips when the bag broke.The tips of the prongs were not exposed.It is unknown if there were multiple attempts to advance the actuator a third inzii was opened to complete the case.There was no patient injury.There are no photos available.The device was discarded after the case.The account manager reminded the facility to save any devices in the future for evaluation.Patient status: no patient injury occurred.Type of intervention: opened another inzii to complete the case.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical was unable to confirm the complainant¿s experience of a broken tissue bag.In the absence of the event unit, it is difficult to determine if the broken tissue bag was caused by a device non-conformance.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event based on the description 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

Name of procedure being performed: laparoscopy.The account manager was not present for the case.Limited information was provided when the account manager reached out for additional information regarding the event.The second inzii was deployed and it was being use to fish out uterine clips when the bag broke.The tips of the prongs were not exposed.It is unknown if there were multiple attempts to advance the actuator a third inzii was opened to complete the case.There was no patient injury.There are no photos available.The device was discarded after the case.The account manager reminded the facility to save any devices in the future for evaluation.Patient status: no patient injury occurred.Type of intervention: opened another inzii to complete the case.

• 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
• MDR Report Key: 10932159
• MDR Text Key: 219380972
• Report Number: 2027111-2020-00632
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)221229(30)01(10)1377525
• Combination Product (y/n): N
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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: No Information
• Device Expiration Date: 12/29/2022
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1377525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 01/28/2021
• Patient Sequence Number: 1