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

Model Number	CTR33
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic bariatric surgery.Event description: during surgery, the endoscope did not pass smoothly through this trocar and felt somewhat stuck.The user previously reported a similar issue in case (b)(4) last year.Recently, they have frequently encountered the same issue with the ctr33 model, though no formal complaint was filed until now.Since the user cannot recall the exact dates of each occurrence, they are unable to provide a detailed list.For now, they will focus on returning the defective product as a reference for this issue.There is no impact to patient.The user was unable to resolve the issue and had to continue using the device despite the difficulty.The problem was only resolved after switching to another trocar.There is no other instruments to affect this event.Additional information provided by the distributor on 15nov2024 via email: the obturator was too loose within the cannula.Yes, there is resistance when moving the obturator in and out of the cannula.It's not possible to determine any damage from an external inspection.Intervention: the user was unable to resolve the issue and had to continue using the device despite the difficulty.The problem was only resolved after switching to another trocar.Patient status: there is no impact to patient.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of drag force.Based on the condition of the returned unit, it is likely that the reported event was caused by an improperly seated shield, an internal plastic component, which resulted in drag force as a larger surface area of the septum, an internal rubber component, was coming into contact with the scope.However, the exact root cause of the dislodged shield within the seal subassembly could not be confirmed.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: laparoscopic bariatric surgery.Event description: during surgery, the endoscope did not pass smoothly through this trocar and felt somewhat stuck.The user previously reported a similar issue in case cer (b)(4) last year.Recently, they have frequently encountered the same issue with the ctr33 model, though no formal complaint was filed until now.Since the user cannot recall the exact dates of each occurrence, they are unable to provide a detailed list.For now, they will focus on returning the defective product as a reference for this issue.There is no impact to patient.The user was unable to resolve the issue and had to continue using the device despite the difficulty.The problem was only resolved after switching to another trocar.There is no other instruments to effect this event.Additional information provided by the distributor on 15nov2024 via email: the obturator was too loose within the cannula.Yes, there is resistance when moving the obturator in and out of the cannula.It's not possible to determine any damage from an external inspection.Intervention: the user was unable to resolve the issue and had to continue using the device despite the difficulty.The problem was only resolved after switching to another trocar.Patient status: there is no impact to patient.

• 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: 20793364
• Report Number: 2027111-2024-00929
• Device Sequence Number: 15406196
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1533228
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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