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	Difficult to Open or Close (2921); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of the evaluation.
Event or Problem Description
Procedure performed: na (sterile unit returned).Event description: complaint 1 of 4: 2022-000726 [mfr #2027111-2022-00533].Complaint 2 of 4: 2022-001472.Complaint 3 of 4: 2022-001473.Complaint 4 of 4: 2022-001474.While the surgeon was trying to cut using applied medical scissors, the device blocked the jaws.The scissor no longer opened, locking also in the handle.The surgeon also had difficulty removing the device.Additional information received by email from applied medical representative on (b)(6) 2022: yes, the does not work upon initial use just after a few minutes of use the scissors did not open anymore the blades did not open/close fully at the beginning.The scissors were not used to cut staples/ lapband/dense tissue.It was not a dangerous condition, simply the blades of the scissors remained locked in the open position, physiological tissues (peritoneum) were cut and the blades were not damaged.Additional information received by email from applied medical representative on (b)(6) 2022: only one scissors are involved in the accident, but the customer also wants to return the remaining scissors of the defective batch(3 sterile samples).Additional information received by email from applied medical team member on (b)(6) 2022: upon evaluation of the returned event unit and 3 sterile non-event units for complaint 2022-000726, it was found that the 3 sterile units failed the [test method] on (b)(6) 2022 due to burr formation that prevents the unit from being able to actuate.Intervention: na (sterile unit returned).Patient status: na (sterile unit returned).
Event or Problem Description
Procedure performed: na (sterile unit returned).Event description: complaint 1 of 4: (b)(4) [mfr #2027111-2022-00533], complaint 2 of 4: (b)(4) [mfr #2027111-2022-00623], complaint 3 of 4: (b)(4) [mfr #2027111-2022-00624], complaint 4 of 4: (b)(4) [mfr #2027111-2022-00625].While the surgeon was trying to cut using applied medical scissors, the device blocked the jaws.The scissor no longer opened, locking also in the handle.The surgeon also had difficulty removing the device.Additional information received by email from applied medical representative on 16mar22: yes, the does not work upon initial use just after a few minutes of use the scissors did not open anymore the blades did not open/close fully at the beginning the scissors were not used to cut staples/ lapband/dense tissue "it was not a dangerous condition, simply the blades of the scissors remained locked in the open position, physiological tissues (peritoneum) were cut and the blades were not damaged" additional information received by email from applied medical representative on 16mar22: only one scissors are involved in the accident, but the customer also wants to return the remaining scissors of the defective batch (3 sterile samples).Additional information received by email from applied medical team member on 25may22: upon evaluation of the returned event unit and 3 sterile non-event units for complaint (b)(4), it was found that the 3 sterile units failed the [test method] on 10may22 due to burr formation that prevents the unit from being able to actuate.
Additional Manufacturer Narrative
A non-event sterile unit was returned to applied medical for evaluation.Visual inspection and testing performed confirmed the complainant¿s experience as damage to the blades was observed preventing the unit from actuating.Based on the condition of the returned sterile 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.

• 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: 14607139
• Report Number: 2027111-2022-00623
• Device Sequence Number: 20118721
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)241115(30)01(10)1435498
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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
• Device Expiration Date: 11/15/2024
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1435498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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