MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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: laparoscopic esophagectomy.Event description: during the patient¿s chest time, after positioning the hasson trocar, the tip (below the balloon) accidentally broke into two pieces.These fell inside the patient¿s chest and were promptly identified by all members of the team and removed without causing any consequences that could affect the patient¿s safety.Subsequently, the scrub nurses, together with the surgeons and the rest of the team, checked that the pieces matched to verify that they had been removed completely.Additional information received from an applied medical representative via email 07nov25: cannula broken.Identification of the break: intervention of esophagectomy.It was the second time of the intervention (thoracic time) when a trocar (in this case c0r47) is being inserted between two ribs.The patient was with ribs very closed to each other and with little space between one rib and the other.Dr (b)(6) inserted the hasson trocar through a mini open incision as usual with no rotation of the trocar (but with difficulty due to the strict ribs) and put inside the trocar the video camera when he saw three fragments of the trocar laying on the lung surface.He had no problem in recovering them as they were not fragmented in other pieces.Afterwards the scrub nurse has checked that the pieces matched with the remaining part of the cannula and they did.No robot used, no other products involved.Patient ok.Additional information received from an applied medical representative via email 11nov25: i confirm one complaint only, one procedure only.The esophagectomy is performed in two different moments: the first one is abdominal, the second one (with different positioning of the patient) is thoracic.The break of the cannula happened at the beginning of the thoracic time when they inserted hasson between the ribs.Intervention: subsequently, the scrub nurses, together with the surgeons and the rest of the team, checked that the pieces matched to verify that they had been removed completely.Patient status: patient is ok.

• Brand Name: KII BALLOON BLUNT TIP 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: 23570772
• Report Number: 2027111-2025-00864
• Device Sequence Number: 21313427
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060629
• 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): 06/10/2026

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: C0R47
• Device Catalogue Number: 101477565
• Device Lot Number: 1559447
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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