MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INSUFFLATION NEEDLE; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	C2201
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned for evaluation, and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: the veress needle was being used for insufflation.The issue occurred during the insertion of the needle.At that time, the needle perforated the liver.According to the user, no ¿click¿ was perceived when the veress needle passed through the abdominal wall (peritoneum).As a result, the needle was inserted too deeply, which may have led to the liver perforation.The user also reported that the needle did not glide smoothly during insertion.No internal complaint was filed by the customer regarding this incident.However, this information is being reported as it was considered relevant to document the event.The information was relayed indirectly via the hospital pharmacist, who requested the return of the remaining stock (veress needles, reference (b)(4).At this stage, it remains unclear whether the issue is device-related or associated with the use of the device, which may differ from the technique applied with the product previously used by the surgeon.According to the head nurse, a use-related issue is considered more likely.The event was reported as a precaution, as it occurred twice [new complaint created], in order to assess whether similar incidents have been reported, potentially related to the same lot.The lot number is currently being investigated and will be communicated once available.Following the incident, the surgeon decided to discontinue the use of our veress needles.A follow-up discussion with the surgeon is planned.Additional information received by an applied medical representative via email on 29apr26: the only point i can clearly confirm is that these were two different cases involving two different needles from the same lot.The patient is doing well.No complaint was raised following the event, but rather some uncertainty regarding the use of the needle.I do not currently have a video of the procedure, but i can check whether one is available.I will be visiting the site tomorrow and hope to speak directly with the user to gather additional information.Intervention: despite the initial issue, the user attempted to use the needle a second time and encountered the same problem.The user then decided to discontinue the use of our veress needles.Patient status: the patient is doing well.

• Brand Name: INSUFFLATION NEEDLE
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 25174684
• Report Number: 2027111-2026-00556
• Device Sequence Number: 18676510
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K963359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown