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

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: prostatectomy.Event description: the applied medical representative spoke to the surgeon and he told them that was his mistake as he was pulling out, the instrument partially opened.They had to do the report to the health ministry as they could not find a small piece of the trocar.The procedure was already finished when the incident occur.Additional information received from an applied medical representative via email on 15oct2024: it was confirmed it was the cannula that broke.There was no patient injury and patient is ok.Type of intervention: procedure was already finished when the incident occur.Patient status: ok.
Event or Problem Description
Procedure performed: prostatectomy.Event description: the applied medical representative spoke to the surgeon and he told them that was his mistake as he was pulling out, the instrument partially opened.They had to do the report to the health ministry as they could not find a small piece of the trocar.The procedure was already finished when the incident occur.Additional information received from an applied medical representative via email on 15oct24: it was confirmed it was the cannula that broke.There was no patient injury and patient is ok.Additional information received from an applied medical representative via email on 25oct24: the territory manager sent over the report that was submitted to nca by customer.It was reported to the italian nca with the following : completed the radical prostatectomy surgery with extraction of the trocar it was evident that the plastic end of the same.One was able to recover a fragment of about 3 mm but could not recover another one of equal size that remained in the abdominal muscle tissue.Type of intervention: procedure was already finished when the incident occur.Patient status: ok.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records was performed, and no trends were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII SLEEVE
• 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: 20496504
• Report Number: 2027111-2024-00878
• Device Sequence Number: 19857705
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K083638
• 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): 03/06/2025

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: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1521930
• Was Device Available for Evaluation?: No
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown