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

Model Number	CTR73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: the following trocars shattered during a procedure, ref: cfr73 & ctr73.I have in my possession the affected trocars for you to collect.Two separate occurrences.Team was unable to collect wrapping for lot numbers.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not retuned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: unknown.Event description: the following trocars shattered during a procedure ¿ ref: cfr73 & ctr73.I have in my possession the affected trocars for you to collect.Two separate occurrences ¿ team was unable to collect wrapping for lot numbers.Additional information obtained from account manager via email on 28jul2025: hello, i sent this to the university hospital team when you sent it to me but i haven¿t heard anything back yet.I spoke to [account manager] on monday 04 aug 2025 regarding complaint (b)(4).He mentioned that he shared the additional questions along with the status of the devices collected in relation to this complaint with the hospital staff but has not heard back.He mentioned that to his knowledge there was no patient injury associated with this complaint.Additional information obtained from [applied medical clinical development team member] via email on 28jul2025: i spoke to [account manger] on monday 04 aug 2025 regarding complaint (b)(4).He mentioned that he shared the additional questions along with the status of the devices collected in relation to this complaint with the hospital staff but has not heard back.He mentioned that to his knowledge there was no patient injury associated with this complaint.I plan on following up with him on monday (b)(6) 2025 to see if he received a response or any additional information that would be helpful for the investigation.Additional information obtained from [account manager] via voicemail on 19aug2025: the account manager cannot obtain any additional information pertaining to the complaints.Patient status: no patient injury indicated.

• 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: 22681829
• Report Number: 2027111-2025-00669
• Device Sequence Number: 15687678
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: CTR73
• Device Catalogue Number: 101219401
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown