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	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes hysterectomy + usls.Event description: "during the surgery, when the dr.Inserted a 40 size needle to perform the usls procedure, the inner instrument shield (plastic ring similar to the big instrument shield) of the 10mm trocar slipped out of the trocar and slided onto the instrument.The dr.'s analysis is that he might have hit it when inserting the needle into the trocar as it was a big needle (size 40)".Additional information received via email on 24-mar-22: the entire component fell out.The instrument that was inserted in the trocar was a needle holder with a size 40 needle to perform the usls procedure additional information received via email on 06-apr-22 from applied medical product mgr: there was no patient injury associated with the event.There was no effect on patient.Patient status: there was no effect on patient.Type of intervention: the dr.Had to open the gel seal cap and remove the small plastic instrument shield from the instrument and then reattached the gel seal cap and continued the case.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the sleeve, had separated from the sleeve.Based on the condition of the returned unit and the description of the even, it is likely that the reported event 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." in addition, the ifu also states that, "all instruments should be centered axially when inserted through the seal.".
Event or Problem Description
Procedure performed: vnotes hysterectomy + usls.Event description: "during the surgery, when the dr.Inserted a 40 size needle to perform the usls procedure, the inner instrument shield (plastic ring similar to the big instrument shield) of the 10mm trocar slipped out of the trocar and slided onto the instrument.The dr.'s analysis is that he might have hit it when inserting the needle into the trocar as it was a big needle (size 40)".Additional information received via email on 24-mar-22: the entire component fell out.The instrument that was inserted in the trocar was a needle holder with a size 40 needle to perform the usls procedure.Additional information received via email on 06-apr-22 from applied medical product mgr: there was no patient injury associated with the event.There was no effect on patient.Patient status: there was no effect on patient.Type of intervention: the dr.Had to open the gel seal cap and remove the small plastic instrument shield from the instrument and then reattached the gel seal cap and continued the case.

• 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: 14079155
• Report Number: 2027111-2022-00552
• Device Sequence Number: 19366836
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)241017(30)01(10)1432489
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 10/17/2024
• Device Model Number: C2A12
• Device Catalogue Number: 101474456
• Device Lot Number: 1432489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE HOLDER
• Patient Sex: Unknown