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

Model Number CD001

Device Problem Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 08/25/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: laparoscopic cholecystectomy.Dr performing a lap chole experienced issues with cd001.Dr has used this bag for many years.Dr was using cff03 and cor47 port, dr placed the gallbladder in the cd001 and pulled the string to tighten the bag ready for retrieval.Dr said the bag did not close correctly and it leaked bile into the abdomen resulting him in having to wash the abdomen with 6 litres of ns and the patient has had to stay in hospital with 2 drains post op.Dr said that this issue had occurred repeated itself 3 times now on separate occasion.The device was not kept due to its condition after the leak.Additional information received from sales rep via email on 02sep2019: i think i did state that the bag leaked at the bead end and did not close properly and did not burst in my original cer.Additional information received from sales rep via email on 19sep2019: he cannot remember when the other 2 times occurred unfortunately.Patient status: stayed in hospital for a number of days with 2 drains in abd complaining.Type of intervention: washed the abdomen with 6l of ns and patient had to stay in hospital with 2 drains post op.

Event Description

Procedure performed: laparoscopic cholecystectomy dr performing a lap chole experienced issues with cd001.Dr has used this bag for many years.Dr was using cff03 and cor47 port, dr placed the gallbladder in the cd001 and pulled the string to tighten the bag ready for retrieval.Dr said the bag did not close correctly and it leaked bile into the abdomen resulting him in having to wash the abdomen with 6 litres of ns and the patient has had to stay in hospital with 2 drains post op.Dr said that this issue had occurred repeated itself 3 times now on separate occasion.The device was not kept due to its condition after the leak.Additional information received from sales rep via email on 02sep2019: i think i did state that the bag leaked at the bead end and did not close properly and did not burst in my original cer.Additional information received from sales rep via email on 19sep2019: he cannot remember when the other 2 times occurred unfortunately.Patient status: stayed in hospital for a number of days with 2 drains in abd complaining.Type of intervention: washed the abdomen with 6l of ns and patient had to stay in hospital with 2 drains post op.

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.At this time, applied medical is unable to confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 9121065
• MDR Text Key: 177966929
• Report Number: 2027111-2019-00599
• Device Sequence Number: 1
• Product Code: GCJ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization