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

Model Number CD001

Device Problem Component Missing (2306)

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

Event Date 07/14/2021

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 investigation.

Event Description

Type of procedure performed: ni.I contacted both [name] and [name] for additional information but they have not been able to give me more information within the 24 hour period required for me to submit the cer.All i know is what was written on the back of the product packaging which stated: "faulty system" bag not attached to the metal.I have been unable to ascertain whether this was before, during, or post treatment.[name] said he would get more information and [name] also said she would get more information.I have made 3 follow up phone calls and send 1 email in this regard.I will add more information once it is relayed to me.Additional information received via email from [name] on 19 july 2021: here are is the additional information from the customer relating to the cer i completed.As per the phone call i received from [name] in (b)(6), i was asked to add this onto an email instead of completing an additional cer form.Name of surgeon: [name] date the event happened.Wednesday (b)(6).Name of the procedure being performed.Lap cholecystectomy.Timing of the event: before use, or during treatment, or post treatment during treatment: instrument was inside patient.Did a patient injury or illness occur associated with the complaint event? no.Patient status (what happened as a result of this event) no issues.Detailed description of event: in as much details as possible, please describe the event (eg.When in the procedure did the event occur, who was using the item and how were they using it at the time of the event, what other products were involved, etc.Feedback from nurse [name] - "bag was not attached to the metal".Patient status: ni.Type of intervention: ni.

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 damages or non-conformances that could have contributed to the reported event.In the absence of the event unit, applied medical is unable to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

Event Description

Type of procedure performed: laparoscopic cholecystectomy.I contacted both [name] and [name] for additional information but they have not been able to give me more information within the 24 hour period required for me to submit the cer.All i know is what was written on the back of the product packaging which stated: "faulty system" bag not attached to the metal.I have been unable to ascertain whether this was before, during, or post treatment.[name] said he would get more information and [name] also said she would get more information.I have made 3 follow up phone calls and send 1 email in this regard.I will add more information once it is relayed to me.Additional information received via email from [name] on 19 july 2021: here are is the additional information from the customer relating to the cer i completed.As per the phone call i received from [name] in australia, i was asked to add this onto an email instead of completing an additional cer form.¿ name of surgeon: [name] ¿ date the event happened.Wednesday 14 july ¿ name of the procedure being performed.Lap cholecystectomy ¿ timing of the event: before use, or during treatment, or post treatment during treatment - instrument was inside patient ¿ did a patient injury or illness occur associated with the complaint event? no ¿ patient status (what happened as a result of this event) no issues ¿ detailed description of event: in as much details as possible, please describe the event (eg.When in the procedure did the event occur, who was using the item and how were they using it at the time of the event, what other products were involved, etc.Feedback from nurse [name] - "bag was not attached to the metal" patient status: no issues type of intervention: ni.

• 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: 12215218
• MDR Text Key: 263124025
• Report Number: 2027111-2021-00581
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230924(30)01(10)1397076
• 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: 09/30/2021

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 Expiration Date: 09/24/2023
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1397076
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1