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

Model Number	CTB71
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
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
Procedure performed: thoracoscopy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).[translation].I have just received a bag from the operating theatre of the visceral surgery department and it contains 2 trocars including packaging.In both cases, the item is ctb71 with an identical lot number (1514503) and in both cases the trocar is broken at the shaft.It all happened during a patient, i.E.An operation, and the surgeon was more than experienced (head physician of the department with senior physician as assistant).The tm also submitted an email summarizing the events mentioned by the healthcare user after she had communication with the healthcare user.She did state the patient was good.Additional information received via the customer via tm later on 30dec24: the tm stated new information was received, it seems there were two different trocars within the same prodcedure.The customer stated the following: [translation].Unfortunately, the whole event was a bit more complicated: there were two different trocars, one had the data i already given, but the second was a short variant (ref cts22) and unfortunately, we don't have any packaging for it anymore and also the box from which the article came was already disposed of this morning (the said trocar had been the last one).The colleagues in the hall then gave me the second trocar in the wrong outer packaging and since both trocars were broken, no one could easily recognize that these were specimens of different lengths.The chief physician i asked about the incident just told me that both fractures occurred during the ongoing operation, not during insertion or anything.Additional information received from an applied medical representative via email on 06jan25: the procedure took place on (b)(6) 2024.Both times the cannula broke and all pieces removed from the patient.This was not a robotic procedure.With both cannula the obturator was not inserted at the time of incident.Intervention: new trocar used.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The cannula wall thickness near the fracture location was measured and did not meet specifications.Based on the condition of the returned unit, it¿s likely that the reported event was due to the uneven cannula wall thickness making the cannula more susceptible to fracturing.Applied medical has performed a historical trend analysis and review of production records and no documentation was identified.
Event or Problem Description
Procedure performed: thoracoscopy.Event description: complaint 1 of 2: (b)(4) (mfr # 2027111-2025-00312).Complaint 2 of 2: (b)(4) (mfr # 2027111-2025-00311).[translation] i have just received a bag from the operating theatre of the visceral surgery department and it contains (b)(4) trocars including packaging.In both cases, the item is ctb71 with an identical lot number (1514503) and in both cases the trocar is broken at the shaft.It all happened during a patient, i.E.An operation, and the surgeon was more than experienced (head physician of the department with senior physician as assistant).I have sent a makeshift photo and you can roughly recognise the fracture lines.The (b)(6) also submitted an email summarizing the events mentioned by the healthcare user after she had communication with the healthcare user.She did state the patient was good.Additional information received via the customer via (b)(6) later on (b)(6) 2024: the (b)(6) stated new information was received, it seems there were two different trocars within the same prodcedure.The customer stated the following: [translation] unfortunately, the whole event was a bit more complicated: there were two different trocars, one had the data i already given, but the second was a short variant (ref (b)(4)) and unfortunately, we don't have any packaging for it anymore and also the box from which the article came was already disposed of this morning (the said trocar had been the last one).The colleagues in the hall then gave me the second trocar in the wrong outer packaging and since both trocars were broken, no one could easily recognize that these were specimens of different lengths.Stupid run.The chief physician i asked about the incident just told me that both fractures occurred during the ongoing operation, not during insertion or anything.Additional information received from an applied medical representative via email on 06jan 2025: (b)(6) confirmed only (b)(4) devices are returning.It was confirmed ctb71 lot 1514503 is correct.Cts22 lot unk will not be returning in its original packaging rather in another packaging.Both of the trocars were used on the same procedure.The procedure took place on (b)(6) 2024.Both times the cannula broke and all pieces removed from the patient.This was not a robotic procedure.With both cannula the obturator was not inserted at the time of incident.Additional information received from an applied medical representative via email on 21jan 2025: updated concomitant devices and patient status.It was confirmed there was no patient injury.The trocar was inserted the correct and provided way and there was no difficulty during insertion.Intervention: new trocar used.Patient status: no patient injury or illness was reported.

• Brand Name: KII SHIELDED BLADED 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: 21105398
• Report Number: 2027111-2025-00312
• Device Sequence Number: 8757997
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072674
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1514503
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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