MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD003

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Procedure performed: lap appendectomy.Event description: the following information was received on 11 january 2023 via email as part of the response for the request for additional information for complaint (b)(4): prior to christmas [name] was advised of an issue which appears to be the same as reported in these incidents, however it was not acted upon as was thought to possibly be human error.No details or lot numbers are available.Additional information provided via email from [name] on 12 january 2023: this event before christmas is not related to the information collected for the events in january.I believe the incident was more mentioned in passing to [name] and no details had been collected.The staff were unsure if it was a device event or if human error had played a part in the device not working as intended.Intervention: ni.Patient status: patient was unaffected.

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event of the tissue bag falling off the supports.Based on similar events, the likely root cause of the reported event is retraction prior to full deployment of the tissue bag.The instructions for use (ifu) states, "hold the inzii retrieval system in an upright position and push the thumb ring forward to deploy and advance the rim of the bag into the body cavity.The thumb ring must be pushed completely forward until it has reached its advancing endpoint, which is indicated by a stop.Do not retract prior to full deployment.".

Event Description

Procedure performed: lap appendectomy.Event description: complaint 1 of 4: (b)(4), mfr# 2027111 2023 00331.Complaint 2 of 4: (b)(4), mfr# 2027111 2023 00335.Complaint 3 of 4: (b)(4), mfr# 2027111 2023 00333.Complaint 4 of 4: (b)(4), mfr# 2027111 2023 00334.The following information was received on 11 january 2023 via email as part of the response for the request for additional information for complaint (b)(4): prior to christmas [name] was advised of an issue which appears to be the same as reported in these incidents, however it was not acted upon as was thought to possibly be human error.No details or lot numbers are available.Additional information provided via email from [name] on 12 january 2023: this event before christmas is not related to the information collected for the events in january.I believe the incident was more mentioned in passing to [name] and no details had been collected.The staff were unsure if it was a device event or if human error had played a part in the device not working as intended.Intervention: ni.Patient status: patient was unaffected.

• Brand Name: CD003, 5MM 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16300407
• MDR Text Key: 309522486
• Report Number: 2027111-2023-00334
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K100959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD003
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1