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

Model Number	CTB35
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: coelio sigmoidectomy.Event description: [translation] during a coelio sigmoidectomy: when the trocars were removed at the end of the operation, the end of the trocar was found to be damaged: broken, burnt? the optic (30 mm video laparascope) was placed in this trocar had microchips fallen intra-abdominally? patient status: unknown.
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.Visual inspection confirmed the complainant¿s experience of a fractured cannula.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.A historical trend analysis and review of production records was performed and no relevant documentations were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.
Event or Problem Description
Procedure performed: coelio sigmoidectomy.Event description: [translation] during a coelio sigmoidectomy: when the trocars were removed at the end of the operation, the end of the trocar was found to be damaged: broken, burnt? the optic (30 mm videolaparoscope) was placed in this trocar -> had microchips fallen intra-abdominally? additional information received from applied medical representative via email on 07aug24 in reply to questions: no, the patient did not suffer any injuries.Status: no patient injury reported.No intervention, issue spotted at the end of the procedure once trocar was being removed.Date of event 07/16/2024.No clean rupture: shredded as if melted.Trocar was inserted with rotation.No difficulty with insertion.Not a robotic procedure but laparoscopic.Intervention: no intervention, issue spotted at the end of the procedure once trocar was being removed.Patient status: unknown, no patient injury reported.

• Brand Name: KII SHIELDED BLADED DUAL PACK
• 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: 19913118
• Report Number: 2027111-2024-00775
• Device Sequence Number: 8104449
• Product Code: GCJ
• UDI-Device Identifier: 00607915129897
• UDI-Public: (01)00607915129897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: CTB35
• Device Catalogue Number: 101473280
• Device Lot Number: 1509881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 30 DEGREE VIDEOLAPAROSCOPE; 5MM TROCAR X 2; 5MM TROCAR X 2
• Patient Sex: Unknown