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

Model Number C2A12

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon the completion of investigation.

Event Description

Name of procedure being performed: vnotes hysterectomy.Description transcribed from telephone call with applied medical representative 23nov20: polyurethane sheath has partially separated from the placement ring during vnotes procedure.The damaged alexis was removed, and a new product was opened - the procedure was completed using the alexis from the second package but the original gelport was used.No consequences or injury for patient.The tear occurred from bottom of sheath at the ring, the tear was approximately 2 inches in diameter.The product is in theatres 2 in quarantine.Patient status: no consequences or injury to the patient.Type of intervention: change of device: alexis component.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had separated from the inner ring at the seal line.The inner ring of the event unit was also unflipped.Based on the condition of the returned unit, it is likely the reported event occurred when the event unit was pulled with a large force, which caused the inner ring to unflip and the sheath to separate from the inner ring.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is a follow-up report for medwatch # 01681.

Event Description

Name of procedure being performed: vnotes hysterectomy.Description transcribed from telephone call with applied medical representative 23nov20: polyurethane sheath has partially separated from the placement ring during vnotes procedure.The damaged alexis was removed, and a new product was opened - the procedure was completed using the alexis from the second package but the original gelport was used.No consequences or injury for patient.The tear occurred from bottom of sheath at the ring, the tear was approximately 2 inches in diameter.The product is in theatres 2 in quarantine.Patient status: no consequences or injury to the patient.Type of intervention: change of device - alexis component.

• 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
• MDR Report Key: 11009011
• MDR Text Key: 229322191
• Report Number: 2027111-2020-00643
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)221114(30)01(10)1375255
• Combination Product (y/n): N
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: C2A12
• Device Catalogue Number: 101472317
• Device Lot Number: 1375255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GRASPERS.; SUTURES.; VOYANT HANDPIECE.