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	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: laparoscopic bilateral inguinal hernia repair.Event description: applied team was not present during the case.The surgeon identified the correct approach plane under direct visualization, inserted balloon, and pumped 30 times.Surgeon reports using usual technique and did not expect any complicated patient anatomy.After removing the balloon, placing trocar, and insufflating, half dollar sized tears were found on the far edges of the peritoneum bilaterally.The case was completed successfully using the tep approach with the same device.No patient injury.Product is available for return.Type of intervention: the case was completed successfully using the tep approach with the same device.Patient status: half dollar sized tears were found on the far edges of the peritoneum bilaterally, no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the 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: laparoscopic bilateral inguinal hernia repair.Event description: applied team was not present during the case.The surgeon identified the correct approach plane under direct visualization, inserted balloon, and pumped 30 times.Surgeon reports using usual technique and did not expect any complicated patient anatomy.After removing the balloon, placing trocar, and insufflating, half dollar sized tears were found on the far edges of the peritoneum bilaterally.The case was completed successfully using the tep approach with the same device.No patient injury.Product is available for return.Type of intervention: the case was completed successfully using the tep approach with the same device.Patient status: half dollar sized tears were found on the far edges of the peritoneum bilaterally, no patient injury.

• 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: 14528024
• Report Number: 2027111-2022-00614
• Device Sequence Number: 5837064
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/15/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown