MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0H11, KII DISSECTING BALLOON, OVL, 3/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0H11
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia repair.Event description: the rep was not present for the case.During the case the surgeon claimed the device was not dissecting properly as it was not separating the tissue intended for separation.The balloon was inflating unevenly, there were no known previous surgeries for the patient, and there were no revealed anatomical issues that interfered with the inflation of the balloon.The event unit is not available for return as it was discarded but the remainder of the lot will be returning.Intervention: continued to manually dissect with instruments.Patient status: fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, five (5) representative sterile units were returned.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.The returned sterile units met current specifications and there were no visible non-conformances.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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia repair event description: the rep was not present for the case.During the case the surgeon claimed the device was not dissecting properly as it was not separating the tissue intended for separation.The balloon was inflating unevenly, there were no known previous surgeries for the patient, and there were no revealed anatomical issues that interfered with the inflation of the balloon.The event unit is not available for return as it was discarded but the remainder of the lot will be returning.Intervention: continued to manually dissect with instruments.Patient status: fine.

• Brand Name: C0H11, KII DISSECTING BALLOON, OVL, 3/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16422451
• Report Number: 2027111-2023-00357
• Device Sequence Number: 15103731
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)250821(30)01(10)1461305
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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 Expiration Date: 08/21/2025
• Device Model Number: C0H11
• Device Catalogue Number: 101474193
• Device Lot Number: 1461305
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown