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

Model Number	C0R47
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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
Medsun (b)(4).Procedure performed: robotic xi assisted laparoscopic prostatectomy.Event description: initial balloon was defective requiring or team member to obtain a new one and this one worked fine.No adverse problems for the patient resulted with the defective balloon.The sales representative was contacted regarding this event.Device malfunction - that is, the device did not do what it was supposed to do.No exact event date is given, but the event occurred in jun2025.Additional information received from hospital representative via email on 30jun2025: the balloon malfunctioned during insertion/ there was damage to the balloon.The hospital does not know if there was a leak or broken balloon.No sharmp instruments came into contact with the balloon.Additional information received from account manager via email on 30jun2025: the event date was 11jun2025.Intervention: or team member to obtain a new one and this one worked fine.Patient status: no adverse problems for the patient resulted with the defective balloon.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of balloon malfunction.A hole was observed in the balloon.Based on the condition of the returned unit, it is likely the balloon malfunction was caused by contact with a sharp object or instrument.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medsun report # (b)(4).
Event or Problem Description
Medsun (b)(4).Procedure performed: robotic xi assisted laparoscopic prostatectomy.Event description: initial balloon was defective requiring or team member to obtain a new one and this one worked fine.No adverse problems for the patient resulted with the defective balloon.The sales representative was contacted regarding this event.Device malfunction - that is, the device did not do what it was supposed to do.No exact event date is given, but the event occurred in jun2025.Additional information received from hospital representative via email on 30jun2025: the balloon malfunctioned during insertion/ there was damage to the balloon.The hospital does not know if there was a leak or broken balloon.No sharmp instruments came into contact with the balloon.Additional information received from account manager via email on 30jun2025: the event date was 11jun2025.Intervention: or team member to obtain a new one and this one worked fine.Patient status: no adverse problems for the patient resulted with the defective balloon.
Event or Problem Description
Medsun (b)(4).Procedure performed: robotic xi assisted laparoscopic prostatectomy.Event description: initial balloon was defective requiring or team member to obtain a new one and this one worked fine.No adverse problems for the patient resulted with the defective balloon.The sales representative was contacted regarding this event.Device malfunction - that is, the device did not do what it was supposed to do.No exact event date is given, but the event occurred in jun2025.Additional information received from hospital representative via email on 30jun2025: the balloon malfunctioned during insertion/ there was damage to the balloon.The hospital does not know if there was a leak or broken balloon.No sharmp instruments came into contact with the balloon.Additional information received from account manager via email on 30jun2025: the event date was 11jun2025.Intervention: or team member to obtain a new one and this one worked fine.Patient status: no adverse problems for the patient resulted with the defective balloon.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of balloon malfunction.A hole was observed in the balloon.Based on the condition of the returned unit, it is likely the balloon malfunction was caused by contact with a sharp object or instrument.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medsun report # (b)(4).[correction] related report number has been provided in section h10.

• 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: 22388570
• Report Number: 2027111-2025-00624
• Device Sequence Number: 8761358
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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: C0R47
• Device Catalogue Number: 101477456
• Device Lot Number: 1552384
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/25/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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: Male