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

Model Number	C2201
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
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 following the completion of the investigation.
Event or Problem 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.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: two insufflation needle complaints occurred at [facility].Complaint 1 of 2: (b)(4) - c2201 lot #1495499 mfr 202711-2023-00674.Complaint 2 of 2: (b)(4) - c2201 lot# unknown mfr 202711-2023-00635.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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the needle had no visible damages and could puncture tissue repeatedly without any difficulty.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.This event was initially reported based on the initial description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: C2201, 120MM INSUFF NEEDLE XE, 20/BX
• 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: 17936176
• Report Number: 2027111-2023-00634
• Device Sequence Number: 6352181
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767(17)260628(30)01(10)1495499
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: 06/28/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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