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

Model Number	C2A12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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:.
Additional 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
• Common Device Name: 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
• Report Number: 2027111-2022-00463
• Device Sequence Number: 4029971
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)240930(30)01(10)1431125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown