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 Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: lap appendectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Metal prongs deployed and bag release before surgeon performed action.The fault was discovered prior to use.The product is opened in the field and touched by scrubbed nurse, not used with patient.Additional information provided via email from [facility] on 10 january 2023: the error occurred on three occasions, on (b)(6) 2023, and (b)(6) 2023.Device was used in laparoscopic appendicectomy.The item was used on the patient.No injury to the patient.After inserting the bag inside, push the handle to open bag the metal part was got deployed.The user is an experienced person, hopes it is not a human error.Additional information provided via email from [name] on 11 january 2023: 4th january ¿ the incident reported last week took place, but the device had been inserted into the patient as reported later (not just opened in sterile field).A second device (lot number unknown) was also opened after the first incident and had the same issue.They have not reported the second device as an incident internally.All devices were being used in laparoscopic appendectomies.Two devices are being returned ¿ just the introducer, not the bag.The lot numbers are 1452756 from the incident on the 4th and lot number 1456196 from the 9th january.Patients were unaffected.The product in each instance was confirmed as being intact on removal from the packaging and had been inserted into the trocar and deployed by the surgeon.This is when the bag released from the metal prongs prior to the specimen being inserted.Additional information provided via email from [name] on 12 january 2023: yes, this ¿second device (lot unknown)¿ opened and used in the event on (b)(6) 2023.She didn¿t comment on why they didn¿t create a second incident report for the 4th january.Intervention: they were able to use a manual instrument to put the specimen into the bag and retrieve it this way.Patient status: patient was unaffected.

Event Description

Procedure performed: lap appendectomy.Event description: complaint 1 of 4: 2023-000043, mfr# 2027111 2023 00331; complaint 2 of 4: 2023-000080, mfr# 2027111 2023 00335; complaint 3 of 4: 2023-000097, mfr# 2027111 2023 00333; complaint 4 of 4: 2023-000098, mfr# 2027111 2023 00334.Metal prongs deployed and bag release before surgeon performed action.The fault was discovered prior to use.The product is opened in the field and touched by scrubbed nurse, not used with patient.Additional information provided via email from [facility] on 10 january 2023: the error occurred on three occasions, on 04/01/23, and 09/01/23.Device was used in laparoscopic appendicectomy.The item was used on the patient.No injury to the patient.After inserting the bag inside, push the handle to open bag the metal part was got deployed.The user is an experienced person, hopes it is not a human error.Additional information provided via email from [name] on 11 january 2023: 4th january ¿ the incident reported last week took place, but the device had been inserted into the patient as reported later (not just opened in sterile field).A second device (lot number unknown) was also opened after the first incident and had the same issue.They have not reported the second device as an incident internally.All devices were being used in laparoscopic appendectomies.Two devices are being returned ¿ just the introducer, not the bag.The lot numbers are 1452756 from the incident on the 4th and lot number 1456196 from the 9th january.Patients were unaffected.The product in each instance was confirmed as being intact on removal from the packaging and had been inserted into the trocar and deployed by the surgeon.This is when the bag released from the metal prongs prior to the specimen being inserted.Additional information provided via email from [name] on 12 january 2023: yes, this ¿second device (lot unknown)¿ opened and used in the event on 4 january 2023.She didn¿t comment on why they didn¿t create a second incident report for the 4th january.Intervention: they were able to use a manual instrument to put the specimen into the bag and retrieve it this way.Patient status: patient was unaffected.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, without the bag.Visual inspection confirmed the complainant's experience of the tissue bag falling off the metal supports.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event 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.

• 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: 16287964
• MDR Text Key: 309411164
• Report Number: 2027111-2023-00331
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)250531(30)01(10)1452756
• 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: 05/03/2023

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: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1452756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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