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

Model Number	CB030
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: [institution] report from the sales rep when the scissors were inserted from the trocar, the scissors was stuck open in the abdominal cavity and would not return.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.A part of the blade was shaved and burred.(pic.1) after removing the burrs, it could be opened and closed, although it was stuck.The units will be returned to amr for further evaluation.Admin# (b)(4).Products available for return: 1 package, 1 scissors.Patient status: no patient injury.Intervention: the case was completed with the new one.
Additional 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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the customer¿s experience of the blades not closing as there was damage on the blades, indicating a burr was previously present on the blades.Based on the condition of the returned unit, it is likely that the reported event was cause by the blades interfering with one another, which likely created a burr that prevented the blades from closing.Attempts to close the blade likely resulted in the burr falling off, resulting in the damage observed on the blades.However, the root cause of the blade interference is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unknown.Event description: [institution].Report from the sales rep.When the scissors were inserted from the trocar, the scissors was stuck open in the abdominal cavity and would not return.The case was completed with the new one.Initial investigation report: the event unit was returned to us and visually inspected.A part of the blade was shaved and burred.(pic.1) after removing the burrs, it could be opened and closed, although it was stuck.The units will be returned to amr for further evaluation.Admin# (b)(6).Products available for return: 1 package, 1 scissors.Patient status: no patient injury.Intervention: the case was completed with the new one.

• 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: 16132549
• Report Number: 2027111-2023-00314
• Device Sequence Number: 12296804
• Product Code: FZP
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)241019(30)01(10)1432833
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023
• 2 Devices were Involved in the Event: 1 2

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: 10/19/2024
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1432833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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