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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: laparoscopic bilateral inguinal hernia repair.Event description: the rep was present during the case.At the start of the case, the surgeon dissected down to the desired plane.The surgeon used s retractors during the dissection.Once the surgeon reached the plane, the surgeon placed the balloon at an angle that was almost parallel against the patient.The surgeon made 17 full pumps with the balloon.The surgeon made sure to provide time between each pump to avoid inflating the balloon too rapidly.The surgeon kept the device in position during inflation and did not move the device.The device was inflated under direct visualization using a scope.After the 17 pumps the surgeon noted a tear in the left side of the posterior sheath of the peritoneum.The surgeon removed the balloon and inserted an applied medical kid balloon blunt tip trocar to visualize the peritoneum and confirm the defect.The surgeon then elected to abort the tep approach and inserted trocars through the peritoneum and into the abdominal cavity to proceed with the case laparoscopically.The case was completed successfully and patient status is fine.Patient had a prior bilateral inguinal hernia repair.It is unknown if there were any anatomical issues that interfered with inflation.Product is not available for return.Product was disposed of by the facility.Intervention: the surgeon then elected to abort the tep approach and inserted trocars through the peritoneum and into the abdominal cavity to proceed with the case laparoscopically.Patient status: tear noted in left side of the posterior sheath of the peritoneum.Patient status fine.
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 bilateral inguinal hernia repair.Event description: the rep was present during the case.At the start of the case, the surgeon dissected down to the desired plane.The surgeon used s retractors during the dissection.Once the surgeon reached the plane, the surgeon placed the balloon at an angle that was almost parallel against the patient.The surgeon made 17 full pumps with the balloon.The surgeon made sure to provide time between each pump to avoid inflating the balloon too rapidly.The surgeon kept the device in position during inflation and did not move the device.The device was inflated under direct visualization using a scope.After the 17 pumps the surgeon noted a tear in the left side of the posterior sheath of the peritoneum.The surgeon removed the balloon and inserted an applied medical kid balloon blunt tip trocar to visualize the peritoneum and confirm the defect.The surgeon then elected to abort the tep approach and inserted trocars through the peritoneum and into the abdominal cavity to proceed with the case laparoscopically.The case was completed successfully and patient status is fine.Patient had a prior bilateral inguinal hernia repair.It is unknown if there were any anatomical issues that interfered with inflation.Product is not available for return.Product was disposed of by the facility.Intervention: the surgeon then elected to abort the tep approach and inserted trocars through the peritoneum and into the abdominal cavity to proceed with the case laparoscopically.Patient status: tear noted in left side of the posterior sheath of the peritoneum.Patient status fine.
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 damages or non-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the exact root cause of the injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 13536114
• Report Number: 2027111-2022-00364
• Device Sequence Number: 14471356
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)231022(30)01(10)1400193
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: C0H11
• Device Catalogue Number: 101474193
• Device Lot Number: 1400193
• Was Device Available for Evaluation?: No
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE
• Patient Sex: Unknown