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

Model Number C2201

Device Problem Dull, Blunt (2407)

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

Event Date 08/30/2023

Event Type  malfunction  

Event 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.

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.

• Brand Name: C2201, 120MM INSUFF NEEDLE XE, 20/B
• 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: 17844855
• MDR Text Key: 324913341
• Report Number: 2027111-2023-00612
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767(17)260504(30)01(10)1491501
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 1491501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Date Device Manufactured: 05/05/2023
• 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