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

Model Number CD001

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return for evaluation.A follow-up report will be provided upon completion of the event.

Event Description

Type of procedure performed: lung resection.Hospital: event date is unknown.Complaint was submitted to aomori olympus on 13nov2020."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." "a piece of the bag may remained in the thoracic cavity" "report from the sales rep part of the bag was damaged during tissue recovery and fell into the thoracic cavity.Attempts were made to collect the fallen pieces by cleaning the thoracic cavity, and when the recovered pieces were restored and confirmed to be damaged, it was considered that there was a defect of about 5 mm (some of them fell off and one piece may remained in the thoracic cavity).Initial investigation report the event unit was not returned to us because the sales rep obtained as the past information, we could not confirm the unit condition.The incident will be informed amr for further evaluation.Admin#: (b)(4)." patient status: no patient injury.Intervention: attempts were made to retrieve the pieces from the patient.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical was unable to confirm the complainant¿s experience of a broken tissue bag.In the absence of the event unit, it is difficult to determine if the broken tissue bag was caused by a manufacturing non-conformance.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event based on the description 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

Type of procedure performed: lung resection hospital: [name] event date is unknown.Complaint was submitted to aomori olympus on 13nov2020."this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." "a piece of the bag may remained in the thoracic cavity" "report from the sales rep part of the bag was damaged during tissue recovery and fell into the thoracic cavity.Attempts were made to collect the fallen pieces by cleaning the thoracic cavity, and when the recovered pieces were restored and confirmed to be damaged, it was considered that there was a defect of about 5 mm (some of them fell off and one piece may remained in the thoracic cavity).Initial investigation report the event unit was not returned to us because the sales rep obtained as the past information, we could not confirm the unit condition.The incident will be informed amr for further evaluation.Admin# (b)(4)." additional information received via email on 10dec2020 from [name]: the device was not returned to aomori olympus.It is unknown if the port site was enlarged.Pictures are not available.Product is not available for return.Patient status: no patient injury intervention: attempts were made to retrieve the pieces from the patient.

• Brand Name: CD001, 10MM RETRIEVAL SYS, 10BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11051418
• MDR Text Key: 223159481
• Report Number: 2027111-2020-00642
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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 Model Number: CD001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1