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	Perforation (2001)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
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
Procedure performed: bilateral inguinal hernia repair.Event description: the rep was present during the case.At the start of the procedure, the surgeon made the dissection and inserted the dissecting balloon device into the incision.The surgeon inserted the 10mm scope and then attached the bulb tubing and started pumping the bulb under visualization.After about 10-11 pumps the surgeon noted that the fascia on the left side of the patient was damaged and had a hole.The surgeon believes this damage was caused by the balloon.The surgeon did not move the device during inflation.The exact size of the hole was not specified to the rep.After the hole was noted, the surgeon continued forward with the tep approach.The surgeon had to insert an additional trocar into the patient due to insufflation leakage that the surgeon attributed to the hole in the fascia.The surgeon used an energy device to close the defect in the fascia.The procedure was completed and patient status is fine.The patient has no prior surgeries, no anticipated complications, and no comorbidities.Product is available for return.Intervention: after the hole was noted, the surgeon moved forward with the tep approach.The surgeon had to insert an additional trocar into the patient.The surgeon used an energy device to close the defect in the fascia.Patient status: patient is currently fine.
Event or Problem Description
Procedure performed: bilateral inguinal hernia repair.Event description: the rep was present during the case.At the start of the procedure, the surgeon made the dissection and inserted the dissecting balloon device into the incision.The surgeon inserted the 10mm scope and then attached the bulb tubing and started pumping the bulb under visualization.After about 10-11 pumps the surgeon noted that the fascia on the left side of the patient was damaged and had a hole.The surgeon believes this damage was caused by the balloon.The surgeon did not move the device during inflation.The exact size of the hole was not specified to the rep.After the hole was noted, the surgeon continued forward with the tep approach.The surgeon had to insert an additional trocar into the patient due to insufflation leakage that the surgeon attributed to the hole in the fascia.The surgeon used an energy device to close the defect in the fascia.The procedure was completed and patient status is fine.The patient has no prior surgeries, no anticipated complications, and no comorbidities.Product is available for return.Additional information received via email on 17jan2022 from applied medical representative: the scope used was "[device name]".The patient did not have any anatomical issues that interfered with inflation.The fascia defect was about 3cm in diameter.Additional information received via phone on 20jan2022 from applied medical representative: the surgeon described the hernia as a direct hernia.The surgeon has photos of the defect on a flash drive and the rep will attempt to retrieve a copy of those photos.Additional information received via email on 24jan2022 from applied medical representative: "the doctor was not able to locate the photos." additional information received via email on 15feb2022 from applied medical representative: "the defect that occurred was through the posterior sheath of the peritoneum." intervention: after the hole was noted, the surgeon moved forward with the tep approach.The surgeon had to insert an additional trocar into the patient.The surgeon used an energy device to close the defect in the fascia.Patient status: patient is currently fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.The event unit functioned as intended and there were no visible non-conformances.Based on input received from applied medical clinical subject matter experts, it is possible that the reported event was caused by incorrect placement or torquing of the unit.It is also possible that the balloon did not unfurl properly.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: 13253242
• Report Number: 2027111-2022-00317
• Device Sequence Number: 4431902
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)240728(30)01(10)1424988
• 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): 04/04/2022

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: 07/28/2024
• Device Model Number: C0H11
• Device Catalogue Number: 101474193
• Device Lot Number: 1424988
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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: 10MM SCOPE; OLYMPUS - HD 10MM RIGID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown