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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic myomectomy.Event description: during the procedure the scissors handle got jammed, we had to open a new device (cb030) and the procedure was completed successfully.Additional information received from distributor via email 19sep22: the device was difficult to actuate from the beginning when dr tries to open jaws once entering patient.Handle jammed repeatedly.The device was non-functional upon initial use.The user was cutting adhesions within the abdomen from previous lap surgery.Intervention: device replacement.Patient status: patient was not hurt, only that the scissors handle jammed.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic myomectomy.Event description: during the procedure the scissors handle got jammed, we had to open a new device (cb030) and the procedure was completed successfully.Additional information received from distributor via email 19sep22: the device was difficult to actuate from the beginning when dr tries to open jaws once entering patient.Handle jammed repeatedly.The device was non-functional upon initial use.The user was cutting adhesions within the abdomen from previous lap surgery.Intervention: device replacement.Patient status: patient was not hurt, only that the scissors handle jammed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing was performed on the returned unit, however, the complainant¿s experience could not be replicated or confirmed.The device was able to actuate with the handle without difficulty and the blade was able to open and close properly, the event unit functioned as intended.The event unit was then tested on dense material and visual inspection noted a large burr on one of the blades afterwards.The burr prevented the unit from actuating.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 or confirm that a product malfunction occurred.The formed burr likely resulted from the scissor blades interfering with one another.However, the exact root cause of the blades interfering with one another is unknown.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 15577507
• Report Number: 2027111-2022-00768
• Device Sequence Number: 12439140
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250707(30)01(10)1459465
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 07/07/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1459465
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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