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); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Report from the sales rep: the doctor was tried to resect the tissue using cb030 during the procedure, but the scissors did not close.The doctor switched to the same product, but the scissors did not close the second one as well.Completed the procedure by switching to another product.Initial investigation report: the event unit was returned to us and visually inspected.There were scratches on the medial of the blade.There was a scratch on the distal of the blade.The units will be returned to amr for further evaluation.Product available for return: 1 scissors.Patient status: "no patient injury".Intervention: "the doctor switched to the same product, but the scissors close the second one as well.Completed the procedure by switching to another product.".
Event or Problem Description
Procedure performed: unknown event description: complaint 1 of 2: (b)(4) [mfr #2027111-2022-00809] complaint 2 of 2: (b)(4) [mfr #2027111-2022-00810] report from the sales rep the doctor was tried to resect the tissue using cb030 during the procedure, but the scissors did not close.The doctor switched to the same product, but the scissors did not close the second one as well.Completed the procedure by switching to another product.Initial investigation report the event unit was returned to us and visually inspected.There were scratches on the medial of the blade.There was a scratch on the distal of the blade.The units will be returned to amr for further evaluation.Product available for return: 1 scissors.Patient status: "no patient injury" intervention: "the doctor switched to the same product, but the scissors close the second one as well.Completed the procedure by switching to another product.".
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, 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.

• 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: 15762141
• Report Number: 2027111-2022-00810
• Device Sequence Number: 20890244
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250508(30)01(10)1451961
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 05/08/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1451961
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown