MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap chole/colectomy.Rep was not present for case.The device broke & left a piece behind in the patient when it was deployed.The piece was retrieved from the patient.No patient injury.Another cd001 was opened and used to complete the case.Device was discarded by the facility.Additional information received via email on 23jul2019 from applied medical account mgr: "it was the very tip of the bag that broke.The area indicated by the number one on the diagram.It broke as we were pulling the bag which contained an enlarged gallbladder out of a laparoscopic port.The metal parts of it had already been removed.As had the plunger and activator.The string was still attached.The fact that the bag broke was not the reason i was concerned.When bags are put under stress during removal, all of them can sometimes tear.My concern was that when it broke there was a circular piece of the plastic that completely separated from the rest of the bag.A mere tear in the bag would have been no big deal.The fact that a piece of clear plastic completely separated from the bag meant that it could have easily been left in the patient accidentally.Fortunately it came out along with the gallbladder and we were able to compare the disc of plastic with the remainder of the bag and confirmed that we had all of the pieces." intervention: opened another cd001 and completed case.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be confirmed.In the absence of the event unit, it is difficult to determine the exact 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.

Event Description

Procedure performed: lap chole/colectomy.Rep was not present for case.The device broke & left a piece behind in the patient when it was deployed.The piece was retrieved from the patient.No patient injury.Another cd001 was opened and used to complete the case.Device was discarded by the facility.Additional information received via email on 23jul2019 from applied medical account mgr."it was the very tip of the bag that broke.The area indicated by the number one on the diagram.It broke as we were pulling the bag which contained an enlarged gallbladder out of a laparoscopic port.The metal parts of it had already been removed.As had the plunger and activator.The string was still attached.The fact that the bag broke was not the reason i was concerned.When bags are put under stress during removal, all of them can sometimes tear.My concern was that when it broke there was a circular piece of the plastic that completely separated from the rest of the bag.A mere tear in the bag would have been no big deal.The fact that a piece of clear plastic completely separated from the bag meant that it could have easily been left in the patient accidentally.Fortunately it came out along with the gallbladder and we were able to compare the disc of plastic with the remainder of the bag and confirmed that we had all of the pieces." intervention: opened another cd001 and completed case.Patient status: no patient injury.

• Brand Name: CD001, 10MM 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: 8876381
• MDR Text Key: 177970461
• Report Number: 2027111-2019-00549
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)220326(30)01(10)1352344
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1352344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1