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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia repair.The account mgr was not present for the case.The insufflation needle was attached to the insufflation tubing.Dr [name] couldn't get any insufflation after inserting the needle.When trying to remove the insert, pulled out the entire needle.It is unknown if there was any noticeable leakage.Opened a new insufflation needed and continued the case without further issue.There was no patient injury.The device is available for return.Intervention: opened a new insufflation needle to complete the case.Patient status: no patient injury.
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 was unable to be confirmed as testing indicated that the minimum flow rate was met.Engineering observed that the tube was damaged, and the stylet was stuck inside the tube.Based on the condition of the returned unit, it is possible that the reported event was caused by the stylet that was stuck inside the tube.However, this could not be confirmed as the returned unit performed as expected.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia repair.The account mgr was not present for the case.The insufflation needle was attached to the insufflation tubing.Dr carrillo couldn't get any insufflation after inserting the needle.When trying to remove the insert, pulled out the entire needle.It is unknown if there was any noticeable leakage.Opened a new insufflation needed and continued the case without further issue.There was no patient injury.The device is available for return.Intervention: opened a new insuflation needle to complete the case.Patient status: no patient 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
• MDR Report Key: 11369406
• Report Number: 2027111-2021-00343
• Device Sequence Number: 3781251
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767(17)230819(30)01(10)1394354
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 08/19/2023
• Device Model Number: C2201
• Device Catalogue Number: 101465044
• Device Lot Number: 1394354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1