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

Model Number	C0R47
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	11/05/2025
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 cystectomy.Event description: "[translation]" trocart abdo endochir blunt tip balt d.5-12mm l.100mm open coelio, reference (b)(4), batch 1560795 this incident was reported on (b)(6) 2025 by the gynecology operating room department at "[hospital name]".Description of the incident: loss of the trocar reducer (which fell into the intraperitoneal cavity) during a laparoscopic cystectomy.It was removed and the procedure continued.Additional information received by an applied medical representative via email on 17dec25: no additional info (event date confirmed).Intervention: it was removed and the procedure continued.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complaint¿s experience of seal component dislodgment.Based on the description of the event and the condition of the returned unit, it is likely the reported event was caused by an asymmetrical instrument that was inserted through the trocar in a non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ applied medical has performed a historical trend analysis and review of production records, and no relevant documentation was identified.
Event or Problem Description
Procedure performed: laparoscopic cystectomy.Event description: "[translation]" trocart abdo endochir blunt tip balt d.5-12mm l.100mm open coelio, reference c0r47, batch 1560795 this incident was reported on (b)(6) 2025 by the gynecology operating room department at "[hospital name]".Description of the incident: loss of the trocar reducer (which fell into the intraperitoneal cavity) during a laparoscopic cystectomy.It was removed and the procedure continued.Additional information received by an applied medical representative via email on 17dec2025: no additional info (event date confirmed).Intervention: it was removed and the procedure continued.Patient status: no patient injury or illness was reported.

• 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: 23866664
• Report Number: 2027111-2025-00936
• Device Sequence Number: 4438500
• Product Code: GCJ
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 1560795
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown