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	Peritoneal Laceration(s) (2003)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: right laparoscopic inguinal hernia repair with tep approach.Event description: rep was present for the case.Upon initial insertion into the pre-peritoneal space the surgeon heard a loud popping noise after inserting the dissecting balloon.The surgeon reinserted the balloon and inflated about 40 times then waited approximately 15 second, let the air out of the balloon, removed the device and inserted a c0r47 trocar with a scope.The surgeon identified a tear in the right side of the peritoneum about the size of the tip of the dissecting balloon introducer.The patient is ok and the case was able to be completed with the same device.Product is available for return.Intervention: the case was completed with the same device.Patient status: tear in the patient's peritoneum.Patient is ok.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as there is no indication of a product malfunction based on the event description.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 device was placed in the incorrect plane.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.
Event or Problem Description
Procedure performed: right laparoscopic inguinal hernia repair with tep approach.Event description: rep was present for the case.Upon initial insertion into the pre-peritoneal space the surgeon heard a loud popping noise after inserting the dissecting balloon.The surgeon reinserted the balloon and inflated about 40 times then waited approximately 15 second, let the air out of the balloon, removed the device and inserted a c0r47 trocar with a scope.The surgeon identified a tear in the right side of the peritoneum about the size of the tip of the dissecting balloon introducer.The patient is ok and the case was able to be completed with the same device.Product is available for return.Intervention: the case was completed with the same device.Patient status: tear in the patient's peritoneum.Patient is ok.

• 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: 15189012
• Report Number: 2027111-2022-00690
• Device Sequence Number: 12256670
• Product Code: GCJ
• UDI-Device Identifier: 00607915136703
• UDI-Public: (01)00607915136703(17)250208(30)01(10)1444483
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 02/08/2025
• Device Model Number: C0H11
• Device Catalogue Number: 101474193
• Device Lot Number: 1444483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: C0R47, SCOPE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown