MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	CB030
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: when trying maneuver device it felt stiff/difficult and also seems blunt (difficult to cut tissue).User replaced device.Additional information received via email from [name] on 10 june 2022: 1.Patient status following the procedure: i am unable to obtain any further information.2.Name of procedure being performed: i am unable to obtain any further information.3.Reason why the product is not returning for investigation: it has been disposed.Intervention: replaced.Patient status: ni.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Additional 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.In the absence of the event unit, it is difficult 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.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: no information.Event description: when trying maneuver device it felt stiff/difficult and also seems blunt (difficult to cut tissue).Additional information received via email from [name] on 10 june 2022: 1.Patient status following the procedure: i am unable to obtain any further information.2.Name of procedure being performed: i am unable to obtain any further information.3.Reason why the product is not returning for investigation: it has been disposed.Intervention: replaced.Patient status: no information.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• 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: 14757765
• Report Number: 2027111-2022-00641
• Device Sequence Number: 6022234
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)240831(30)01(10)1428230
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1428230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown