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 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Name of procedure: laparoscopic cholecystectomy.Detailed description of event: the inzii device was used to remove the sample from the patient.After the sample was removed the abdomen was examined and it was found that a piece of the inzii bag was left behind in the patient.The piece was retrieved by the surgical team.No leakage was reported from the bag.The metal prongs were not exposed within the patient.No patient injury.The product is available for return.A photo of the product has been provided.Patient status: no patient injury.Type of intervention: piece of the bag was retrieved from the patient.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering observed that the tissue bag was torn underneath the cuff and a portion of the tissue bag had fragmented.The cord loop was also cut cleanly.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the root cause based on the evaluation of the returned unit.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: laparoscopic cholecystectomy.Detailed description of event: the inzii device was used to remove the sample from the patient.After the sample was removed the abdomen was examined and it was found that a piece of the inzii bag was left behind in the patient.The piece was retrieved by the surgical team.No leakage was reported from the bag.The metal prongs were not exposed within the patient.No patient injury.The product is available for return.A photo of the product has been provided.Additional information received via email on 09sep2020 from [name]: the port site was not enlarged before removal of the specimen.There were no difficulties noted with the removal of the specimen.Patient status: no patient injury.Type of intervention: piece of the bag was retrieved from the patient.

• 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: 10510021
• MDR Text Key: 213904803
• Report Number: 2027111-2020-00553
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230306(30)01(10)1382653
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1382653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1