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

Model Number C2A15

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: tubal ligation.Event description: c2a15 introducer induced trauma to patient's bowel when creating colpotomy.The surgeon sutured the trauma, and the case was completed using the same device as normal.No patient injury occurred.Product is not returning.Intervention: the surgeon sutured the trauma, and the case was completed using the same device as normal.Patient status: c2a15 introducer induced trauma to patient's bowel.No patient injury occurred.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the event unit, it is difficult to determine the root cause of the incident.According to a subject matter expert, a surgeon who is familiar with the device, it is unlikely that the event unit caused the bowel injury due to the bluntness of the introducer.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the injury.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: tubal ligation.Event description: c2a15 introducer induced trauma to patient's bowel when creating colpotomy.The surgeon sutured the trauma, and the case was completed using the same device as normal.No patient injury occurred.Product is not returning.Intervention: the surgeon sutured the trauma, and the case was completed using the same device as normal.Patient status: c2a15 introducer induced trauma to patient's bowel.No patient injury occurred.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15806445
• MDR Text Key: 303740977
• Report Number: 2027111-2022-00823
• 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,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C2A15
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other