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

Model Number C2201

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

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.

Event Description

Procedure performed: laparoscopic cholecystectomy event description: two insufflation needle complaints occurred at [facility].Complaint 1 of 2: (b)(4) - c2201 lot #1495499.Complaint 2 of 2: (b)(4) - c2201 lot# unknown.The surgeon noted that the needle was duller than usual and it was difficult to insert the needle.The stylet was able to be retracted.The surgeon has experienced this multiple times over the past week.No other instruments were being used at the time of the event.No patient injury occurred.The case was completed using the same device.Product is available for return.Additional information was received via email on 03oct2023 from account manager ii, applied medical."they mentioned that this had happened a few times over the prior week but did not know the case dates/times etc.No patients have been hurt and the surgeon used the needle as intended each time, noting that it felt harder to penetrate the peritoneum.I have asked for more information but this is all i have been able to gather.Several others use the veress needle and no one else has complained or had an issue." complaint (b)(4) was created to account for all the other instances that occurred in the past week at the facility.The surgeon has not confirmed the total number of incidents that occurred.Intervention: the case was completed using the same device.Patient status: no patient injury occurred.

• Brand Name: C2201, 120MM INSUFF NEEDLE XE, 20/BX
• Type of Device: 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: 17936176
• MDR Text Key: 325830017
• Report Number: 2027111-2023-00634
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767(17)260628(30)01(10)1495499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2201
• Device Catalogue Number: 101465044
• Device Lot Number: 1495499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1