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

Model Number C2A12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure performed: hysterectomy event description: [translation] a piece of plastic from the vnote valve has come off (transparent).Found in the patient's vagina.Additional information received by email from applied medical representative on 29june22: name of procedure being performed was hysterectomy.Patient status is ok.The valve did separate from the seal he doesn't know if an entire component fall out or if it did appear to be torn all material was retrieved from the patient he doesn't know if any instruments were inserted through the trocar at the time of the event he doesn't know if anything other than instrumentation was placed through the trocar [original].Intervention all material was retrieved from the patient.Patient status: ok.No patient injury has been reported.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the shield, an internal and transparent plastic component of the sleeve, was missing.Based on the condition of the returned unit and the description of the event, it is likely that the shield dislodgement was caused by non-axial insertion or removal of asymmetrical instrumentation 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.All instruments should be centered axially when inserted through the seal.".

Event Description

Name of procedure performed: hysterectomy.Event description: [translation] a piece of plastic from the vnote valve has come off (transparent).Found in the patient's vagina.Additional information received by email from applied medical representative on 29june22: name of procedure being performed was hysterectomy.Patient status is ok.The valve did separate from the seal.He doesn¿t know if an entire component fall out or if it did appear to be torn.All material was retrieved from the patient.He doesn¿t know if any instruments were inserted through the trocar at the time of the event.He doesn¿t know if anything other than instrumentation was placed through the trocar.[original] un bout de plastique provenant de la valve du vnote s'est decroche (transparent).Retrouve dans le vagin de la patiente.Intervention: all material was retrieved from the patient.Patient status: ok.No patient injury has been reported.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5 CM
• 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: 15021220
• MDR Text Key: 297212811
• Report Number: 2027111-2022-00657
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)240823(30)01(10)1428031
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2A12
• Device Catalogue Number: 101474456
• Device Lot Number: 1428031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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