MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII OPTICAL ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0Q19
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	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: na.Event description: we opened another one of this products today, we played with it, introduced the obturator in and out of the seal, and not long enough, the clear piece came off that easily! additional information provided by user facility on 25sep2024 by email: this product was not used on a patient.Additional information provided by user facility on 25sep2024 by email: yes, the device is available for return and i will leave it in mm office.The lot number of the device is not available.The event date is sept.17,2024.Not used during surgery.This was a new item from the shelf we opened to replicate the initial reported product issue.Patient status: not patient related.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Event description: we opened another one of this product today, we played with it, introduced the obturator in and out of the seal, and not long enough, the clear piece came off that easily! additional information provided by user facility on 25sep2024 by email: this product was not used on a patient.Additional information provided by user facility on 25sep2024 by email: yes, the device is available for return and i will leave it in mm office.The lot number of the device is not available.The event date is sept.17,2024.Not used during surgery.This was a new item from the shelf we opened to replicate the initial reported product issue.On 10/2, a medwatch report (b)(4) was sent to the fda by [user facility].Upon further communication with the customer, this was deemed already reported (complaint (b)(4)) to applied medical by other staff from [user facility] and the complaint mistakenly created was voided.Additional information provided by user facility on 04dec2024 by email: after checking, it looks like the report that was internally submitted on 10/2, is for rga# 60901413, which is related to incident reported on 9/17 [complaint (b)(4), mfr report # 2027111-2024-00856] by [user facility].In conclusion, there is only a total of two known incidents.Medwatch form (report #(b)(4)) from fda received by email on 06dec24.Additional information provided by [user facility] on 17dec2024 via email: incident occurring on 9/17 was not reported to the fda.Only two complaint incidents occurred with product# c0q19.Apologies for the back and forth, after re-reading the email chain and checking our product failure logs again, this is my final understanding: the ¿10/2¿ fda reported incident date, was made in error, as this was the date that the product failure report was given to the supply chain team.Patient status: not patient related.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.This report is to follow-up mw # (b)(4).[correction] section d1 has been updated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.However, the complainant¿s experience of shield component detachment could not confirmed as the shield was found within the seal housing.Based on the condition of the returned unit and the description of the event, it is possible that the shield became dislodged from its original position in the seal housing after insertion and/or removal of the obturator.It is also possible that the shield was not properly seated during the manufacturing process.However, the exact root cause of the dislodged shield within the seal housing is unknown.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.This report is to follow up medwatch report # (b)(4).
Event or Problem Description
Procedure performed: na event description: we opened another one of this product today, we played with it, introduced the obturator in and out of the seal, and not long enough, the clear piece came off that easily! additional information provided by user facility on 25sep2024 by email: this product was not used on a patient.Additional information provided by user facility on 25sep2024 by email: yes, the device is available for return and i will leave it in mm office.The lot number of the device is not available.The event date is sept.17,2024.Not used during surgery.This was a new item from the shelf we opened to replicate the initial reported product issue.On 10/2, a medwatch report (# (b)(4) was sent to the fda by [user facility].Upon further communication with the customer, this was deemed already reported (b)(4) to applied medical by other staff from [user facility] and the complaint mistakenly created was voided.Additional information provided by user facility on 04dec2024 by email: after checking, it looks like the report that was internally submitted on 10/2, is for rga# (b)(4), which is related to incident reported on (b)(6) [(b)(4), mfr report # 2027111-2024-00856] by [user facility].In conclusion, there is only a total of two known incidents.Medwatch form (report # (b)(4)) from fda received by email on 06dec24.Additional information provided by [user facility] on 17dec2024 via email: incident occurring on 9/17 was not reported to the fda.Only two complaint incidents occurred with product# c0q19.Apologies for the back and forth, after re-reading the email chain and checking our product failure logs again, this is my final understanding: the ¿10/2¿ fda reported incident date, was made in error, as this was the date that the product failure report was given to the supply chain team.Patient status: not patient related.

• Brand Name: KII OPTICAL ACCESS SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20364071
• Report Number: 2027111-2024-00856
• Device Sequence Number: 17857433
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

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 Model Number: C0Q19
• Device Catalogue Number: 101063001
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/20/2024; 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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