MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A15, GELPOINT V-PATH PLATFORM, 7CM; CULDOSCOPE (AND ACCESSORIES)

Model Number C2A15

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: ovarian cystectomy.Event description: the surgeon was doing a vnotes ovarian cystectomy through a posterior colpotomy.When entering the cavity through the 10mm trocar of the v-path with a laparoscopic reusable scissors, the instrument shield was pushed through the trocar into the abdominal cavity.The surgeon could identify the plastic part within the cavity immediately and removed it from the cavity right away.No clinical impact to the patient.The patient is ok.Removed the part.Other instruments used when the complaint event occurred were laparoscopic 10mm scope and laparoscopic 5mm gasper.Intervention: removed the part patient status: no patient injury.

Event Description

Procedure performed: ovarian cystectomy.Event description: the surgeon was doing a vnotes ovarian cystectomy through a posterior colpotomy.When entering the cavity through the 10mm trocar of the v-path with a laparoscopic reusable scissors, the instrument shield was pushed through the trocar into the abdominal cavity.The surgeon could identify the plastic part within the cavity immediately and removed it from the cavity right away.No clinical impact to the patient.The patient is ok.Removed the part.Other instruments used when the complaint event occurred were laparoscopic 10mm scope and laparoscopic 5mm gasper.Information received from applied medical representative via email 7sep23: the lot number of the event unit is unknown, since the event happened 2 months ago.Intervention: removed the part.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the sleeve.Applied medical¿s instructions for use (ifu) states that, extra care should be taken when inserting and withdrawing angular and asymmetrical instruments, such as "j" hooks and clip appliers.Staplers should be fully closed during passage to avoid potential damage to sleeve.Repeated passage of 12mm staplers may potentially cause seal leakage.All instruments should be centered axially when inserted through the seal.

• Brand Name: C2A15, GELPOINT V-PATH PLATFORM, 7CM
• Type of Device: CULDOSCOPE (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: 17769574
• MDR Text Key: 323660812
• Report Number: 2027111-2023-00596
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care 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: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2A15
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: LAPAROSCOPIC 10MM SCOPE; LAPAROSCOPIC 5MM GASPER; LAPAROSCOPIC REUSABLE SCISSORS