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	04/25/2022
Type of Reportable Event	Malfunction
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 assisted vaginal hysterectomy.Event description: facility: [user facility]."scissors insert to 5mm trocar (lagis) but the tip of scissors can't close.This device function is abnormal.The trocar cannot remove from this pair of scissors due to scissors' flaw.Client returns the defect device together with lagis 5mm trocar.Please consult with attached photos.Patient suffered more wounds when surgeon remove this device.They replaced with a new one to completed this surgery.We offer a ctr03 to make up the customer loss of [competitor] trocar." additional information received via email 28apr2022 from [distributor]: the device was functional upon initial use.The blades did not close fully when the surgeon cut uterine ligaments for some time."the wound must to enlarge 10mm in order to remove the scissors." patient is currently doing well.The case was completed with a new cb030.Intervention: "they replaced with a new one to completed this surgery." patient status: patient is currently doing well.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with the trocar.Visual inspection confirmed the complainant¿s experience as the scissors could not be removed from the trocar due to the blades not closing.Additionally, damage to the blades was observed preventing the unit from actuating.Based on the condition of the returned unit and the description of the event, a burr likely resulted from the scissor blades interfering with one another at their proximal end.However, the exact root cause of the blades interfering with each other 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: laparoscopic assisted vaginal hysterectomy.Event description: facility: [user facility]."scissors insert to 5mm trocar (lagis) but the tip of scissors can't close.This device function is abnormal.The trocar cannot remove from this pair of scissors due to scissors' flaw.Client returns the defect device together with lagis 5mm trocar.Please consult with attached photos.Patient suffered more wounds when surgeon remove this device.They replaced with a new one to completed this surgery.We offer a ctr03 to make up the customer loss of [competitor] trocar." additional information received via email 28apr2022 from [distributor]: the device was functional upon initial use.The blades did not close fully when the surgeon cut uterine ligaments for some time."the wound must to enlarge 10mm in order to remove the scissors." patient is currently doing well.The case was completed with a new cb030.Intervention: "they replaced with a new one to completed this surgery." patient status: patient is currently doing well.

• 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: 14366201
• Report Number: 2027111-2022-00600
• Device Sequence Number: 5640833
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)241019(30)01(10)1432833
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 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: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAGIS 5MM TROCAR
• Patient Sex: Unknown