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

Model Number CD001

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Name of procedure performed: laparoscopic cholecystectomy.Two reps were present during the case.During the lap chole case, the inzii bag initially deployed fine through a 12mm trocar placed at the subxiphoid.The trocar was removed, and the gall baldder was placed into the bag.When the bag was being removed from the patient, the bag broke at the apex, along the seam.The bag was removed from the patient and the 12 mm trocar was reinserted at the subxiphoid incision.An atraumatic grasper was used through the trocar to pick up the gallbladder and remove it from the patient.No patient injury, patient status is stable.Product is available for return.Only the bag is available for return.The rest of the device was disposed of.Patient status: stable, no patient injury.Type of intervention: used an atraumatic grasper to pick up the gall bladder from the patient.

Event Description

Name of procedure performed: laparoscopic cholecystectomy.Two reps were present during the case.During the lap chole case the inzii bag initially deployed fine through a 12mm trocar placed at the subxiphoid.The trocar was removed and the gall baldder was placed into the bag.When the bag was being removed from the patient, the bag broke at the apex, along the seam.The bag was removed from the patient and the 12 mm trocar was reinserted at the subxiphoid incision.An atraumatic grasper was used through the trocar to pick up the gallbladder and remove it from the patient.No patient injury, patient status is stable.Product is available for return.Only the bag is available for return.The rest of the device was disposed of.Patient status: stable, no patient injury.Type of intervention: used an atraumatic grasper to pick up the gall bladder from the patient.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that complainant¿s experience of a torn tissue bag.Engineering observed stretch marks around the break.Based on the condition of the returned unit, it is likely that the bag broke from the stress exerted on the bag while the specimen was being removed from the extraction site.It is possible that the port site was not properly sized for the specimen being removed.The instructions for use (ifu) states that "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal.".

• 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: 10541461
• MDR Text Key: 207190554
• Report Number: 2027111-2020-00560
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)221218(30)01(10)1376847
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1376847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1