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 02/20/2019

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.

Event Description

Procedure performed: lap chole.Surgeon deployed bag, and no bag was in the device.Replaced with another unit and procedure was completed uneventfully.Additional information received via email from account manager on friday, 22feb2019: the device was not actuated/retracted more than once.Before the initial deployment the actuator was normal.The device was not used more than once.As always, i was selective with the wording in the document.They used the device normally.When they deployed the bag, there was no bag on the jaws.They pulled the actuator back to close the jaws, pulled the shaft from the trocar, visualized the area to make certain no pieces were dropped in the patient (negative) and opened another bag to retrieve the specimen uneventfully.After the case (i was not there) they broke the device apart to see if a bag was possibly still in the shaft.There was not.Strangely, the black string was there.But no bag.They have all the pieces together, along with the packaging to return to us and are awaiting instructions on how to do so.Patient status: no patient injury.Type of intervention: replaced with another unit and procedure was completed uneventfully.

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 without 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.

Event Description

Procedure performed: lap chole.Surgeon deployed bag, and no bag was in the device.Replaced with another unit and procedure was completed uneventfully.Additional information received via email from account manager on friday, 22feb2019: the device was not actuated/retracted more than once.Before the initial deployment the actuator was normal.The device was not used more than once.As always, i was selective with the wording in the document.They used the device normally.When they deployed the bag, there was no bag on the jaws.They pulled the actuator back to close the jaws, pulled the shaft from the trocar, visualized the area to make certain no pieces were dropped in the patient (negative) and opened another bag to retrieve the specimen uneventfully.After the case (i was not there) they broke the device apart to see if a bag was possibly still in the shaft.There was not.Strangely, the black string was there.But no bag.They have all the pieces together, along with the packaging to return to us and are awaiting instructions on how to do so.Patient status: no patient injury.Type of intervention: replaced with another unit and procedure was completed uneventfully.

• 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: 8465522
• MDR Text Key: 145655047
• Report Number: 2027111-2019-00402
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)210904(30)01(10)1335421
• 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: 04/18/2019

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: 09/04/2021
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1335421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 04/18/2019
• Patient Sequence Number: 1