MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; GCJ

Model Number CD001

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.This report is connected to medwatch #4600040000-2018-8030.

Event Description

Procedure performed: lap chole.When device was opened, there was no bag.Opened another device and completed procedure.Additional information received via email on 29oct2018 from director clinical engineering at hosp ctr: the applicator is bloody so the problem was discovered as it was attempted to be deployed.When asked if photos could be provided, received the following response.Currently there isn't anything protruding, so i am hesitant to move the device in the sheath before you get a chance to look at it.Additional information received via email on 29oct2018 from general surgery coordinator at hosp ctr: the endocatch was fully deployed (prongs were fully exposed) during use.There was no bag attached and a second endocatch need to be opened.Patient status: no effect.Type of intervention: a second endocatch need to be opened.

Event Description

Procedure performed: lap chole.When device was opened, there was no bag.Opened another device and completed procedure.Additional information received via email on 29oct2018 from director clinical engineering at hosp ctr: the applicator is bloody so the problem was discovered as it was attempted to be deployed.When asked if photos could be provided, received the following response.Currently there isn¿t anything protruding, so i am hesitant to move the device in the sheath before you get a chance to look at it.Additional information received via email on 29oct2018 from general surgery coordinator at hosp ctr: the endocatch was fully deployed (prongs were fully exposed) during use.There was no bag attached and a second endocatch need to be opened.Medwatch (b)(4) received via mail on 15nov2018 from fda.Patient status: no effect.Type of intervention: a second endocatch need to be opened.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the tissue bag.Engineering has reviewed the details surrounding the event and the event unit.At this time, applied medical is unable to confirm that the product was distributed to the customer missing the tissue bag.Although the exact root cause of the reported event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report is to follow up medwatch report # (b)(4).

• Brand Name: CD001, 10MM RETRIEVAL SYSTEM, 10/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8113489
• MDR Text Key: 129308292
• Report Number: 2027111-2018-00444
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)210726(30)01(10)1331627
• Combination Product (y/n): N
• PMA/PMN Number: K060051
• 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: 03/28/2019

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: 07/26/2021
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1331627
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 03/28/2019
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 55