MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5CM; 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 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: vnotes workshop.Event description: cer from vnotes workshop.The following information was provided on 18 february via email by [name]: i need to update you on a product issue.I ran a vnotes workshop today in adelaide with [name] and [name] as faculty.[name] was teaching a couple of consultants with our gelpoint vpath when a suture (see first picture below for details) was introduced into one of the 10mm sleeves, and part of the device popped out and into the simsei.[name] is concerned as the plastic was pushed out from the sleeves.Patient status: na.

Event Description

Procedure performed: vnotes workshop: event description: cer from vnotes workshop the following information was provided on 18 february via email by [name]: i need to update you on a product issue.I ran a vnotes workshop today in adelaide with [name] and [name] as faculty.[name] was teaching a couple of consultants with our gelpoint vpath when a suture (see first picture below for details) was introduced into one of the 10mm sleeves, and part of the device popped out and into the simsei.[name] is concerned as the plastic was pushed out from the sleeves.Patient status:.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo of the shield, an internal plastic component of the sleeve, was provided, confirming the complainant¿s experience of the shield dislodging from the sleeve.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrumentation (such as the suture needle) 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." in addition, the instructions for use (ifu) also states that, "all instruments should be centered axially when inserted through the seal.".

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13796220
• MDR Text Key: 287704829
• Report Number: 2027111-2022-00463
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)240930(30)01(10)1431125
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: 1431125
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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