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	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
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: 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.
Additional 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
• Common Device Name: 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
• Report Number: 2027111-2023-00481
• Device Sequence Number: 14154437
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)260124(30)01(10)1480390
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 01/24/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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