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	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed:gastric band.Event description: les ciseaux ne se ferment pas.[translation] the scissors don't close.Additional information received from applied medical representative via email on 15-mar-2022: the scissors were not used because they were defective upon opening.The surgeon intended to cut the gastric band and gastric band catheter to remove them.The procedure was a gastric band.The date was (b)(6) 2022.The patient did not suffer any injury.Additional information received from applied medical representative via email on 12-apr-2022: the surgeon took an eb210 from another kit.The customer only purchases gk887 kits.Intervention: change to eb210.Patient status: the patient did not suffer any injury.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience as a large burr was observed on one of the blades, preventing the unit from actuating.Based on the condition of the returned unit and the description of the event, the 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: gastric band.Event description: les ciseaux ne se ferment pas.[translation] the scissors don't close.Additional information received from applied medical representative via email on 15-mar-2022: the scissors were not used because they were defective upon opening.The surgeon intended to cut the gastric band and gastric band catheter to remove them.The procedure was a gastric band.The date was march 2, 2022.The patient did not suffer any injury.Additional information received from applied medical representative via email on 12-apr-2022: the surgeon took an eb210 from another kit.The customer only purchases gk887 kits.Intervention: change to eb210.Patient status: the patient did not suffer any injury.

• 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: 14087687
• Report Number: 2027111-2022-00553
• Device Sequence Number: 12059853
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)240909(30)01(10)1429119
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 09/09/2024
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1429119
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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