MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5CM; CULDOSCOPE (AND ACCESSORIES)

Model Number C2A12

Device Problem Entrapment of Device (1212)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

Procedure performed: hysterectomy w/ bso and usls event description: this patient had severe prolapse, and the hysterectomy was performed from a vaginal approach.The surgeon inserted the gelpoint v-path after the hysterectomy to complete the bso and usls.The surgeon did perform a tissue sweep after insertion, but upon entry, noted that the adnexa were trapped behind the inner ring of the alexis.The surgeon related this to the patient's level of prolapse and commented that she did not sweep well enough.The surgeon removed and replaced the alexis and removed the inner ring of the alexis.The patient had a large amount of redundant bowel which required frequent management and retraction throughout the case.During the procedure and well after the insertion of the device, the surgeon noted that there was a minor serosal injury to the rectum, which was successfully repaired with a stitch.The surgeon reported that the injury was associated with her retraction and had nothing to do with the insertion or use of the gelpoint v-path.Product not available for return intervention: the surgeon removed and replaced the alexis and removed the inner ring of the alexis.Patient status: no patient injury indicated.

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.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5CM
• 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: 18243353
• MDR Text Key: 330458551
• Report Number: 2027111-2023-00784
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2A12
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• 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