MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2201, 120MM INSUFF NEEDLE XE, 20/B; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	C2201
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lavh event description: the rep was not present for the case but talked to an er tech who was in the case.Was told that when the device was initially inserted, the tip of the needle hit hard tissue and bent.The device was removed and about less than a quarter inch of the tip of the needle was bent.The case was complete with a new insufflation needle without issue.There was no patient injury and the patient is doing fine.Product is available for return intervention: the case was completed with a new one patient status: patient is fine.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the complainant¿s experience of a bent blunt stylet.It was also observed that the stylet was unable to retract and fully expose the needle.Based on the condition of the returned unit and the description of the event, it is likely that the blunt stylet jammed and failed to expose the needle as it could not retract as intended, which resulted in the stylet bending.Correction: section device code has been updated to (b)(4).- material twisted/bent.
Event or Problem Description
Procedure performed: lavh event description: the rep was not present for the case but talked to an er tech who was in the case.Was told that when the device was initially inserted, the tip of the needle hit hard tissue and bent.The device was removed and about less than a quarter inch of the tip of the needle was bent.The case was complete with a new insufflation needle without issue.There was no patient injury and the patient is doing fine.Product is available for return intervention: the case was completed with a new one patient status: patient is fine.

• Brand Name: C2201, 120MM INSUFF NEEDLE XE, 20/B
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17844855
• Report Number: 2027111-2023-00612
• Device Sequence Number: 17239868
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767(17)260504(30)01(10)1491501
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K963359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 05/04/2026
• Device Model Number: C2201
• Device Catalogue Number: 101465044
• Device Lot Number: 1491501
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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