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 05/10/2023

Event Type  malfunction  

Event Description

Procedure performed: hysterectomy w/ bso and usls.Event description: complaint created based off feedback 5442.Submitted 11may2023.At the end of the procedure, the surgeon pulled the gelseal cap off and noticed that a suturing needle had snagged the seal of the trocar.The seal came off during disassembly.The aps at the case, [name], noted that this incident occurred at the end of the procedure and that there were no issues prior to discovering the seal.She additionally did not notice anything unusual when the surgeon inserted the needle through the trocar sleeve.Additional information received on 23may2023 via email from [name], clinical education specialist.No patient injury occurred.The seal was noticed during disassembly to have come off at some point in the procedure.Intervention: case was completed with the same device.Patient status: no patient injury occurred.

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: hysterectomy w/ bso and usls event description: complaint created based off feedback 5442.Submitted 11may2023.At the end of the procedure, the surgeon pulled the gelseal cap off and noticed that a suturing needle had snagged the seal of the trocar.The seal came off during disassembly.The aps at the case, [name], noted that this incident occurred at the end of the procedure and that there were no issues prior to discovering the seal.She additionally did not notice anything unusual when the surgeon inserted the needle through the trocar sleeve.Additional information received on 23may2023 via email from [name], clinical education specialist no patient injury occurred.The seal was noticed during disassembly to have come off at some point in the procedure.Intervention: case was completed with the same device.Patient status: no patient injury occurred.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is possible that the seal component dislodgement was caused by non-axial insertion or removal of asymmetrical instrumentation through the sleeve.Applied medical¿s instructions for use (ifu) states, "extra care should be taken when inserting and withdrawing angular and asymmetrical instruments, such as "j" hooks and clip appliers, through the sleeves.Staplers should be fully closed during passage to avoid potential damage to sleeve.Repeated passage of 12mm staplers may potentially cause seal leakage.All instruments should be centered axially when inserted through the sleeve 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17083920
• MDR Text Key: 317127423
• Report Number: 2027111-2023-00481
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)260124(30)01(10)1480390
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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: 101474657
• Device Lot Number: 1480390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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