MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0H12, KII DISSECTING BALLOON, RND, 3/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0H12
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/26/2021
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 provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: during the procedure, the dilatation trocar in the abdomen burst! the patient suffered a major hemorrhage.The patient is doing well and the bleeding was stopped by clips.Additional information received from applied medical representative via email on (b)(6) 2021: the volume of blood lost is estimated at about 50 ml.There is no information available about the source of the bleeding.Intervention: clip placement.Patient status: pat.Ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with six representative sterile units.Visual inspection confirmed that the balloon on the event unit had burst as there was a tear in the balloon.Testing was performed on the six representative units.The representative units met current specifications, and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the exact root cause of the patient injury based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: tep hernia/ event description: during the procedure, the dilatation trocar in the abdomen burst! the patient suffered a major hemorrhage.The patient is doing well and the bleeding was stopped by clips.Additional information received from applied medical representative via email on (b)(6) 2021: the volume of blood lost is estimated at about 50 ml.There is no information available about the source of the bleeding.Additional information from bfarm user report received via email (b)(6) 2021: [translation] the dissection balloon burst during regular use as part of tep hernia surgery.The balloon was completely removed.The incident was reported to applied medical's representative.Applied medical has already made a report to the bfarm.All dissection balloons with the above lot number have been returned to the company.No more problems have occurred with the replacement products.Intervention: clip placement.Patient status: pat.Ok.

• Brand Name: C0H12, KII DISSECTING BALLOON, RND, 3/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12418427
• Report Number: 2027111-2021-00616
• Device Sequence Number: 11656889
• Product Code: GCJ
• UDI-Device Identifier: 00607915137229
• UDI-Public: (01)00607915137229(17)240524(30)01(10)1417586
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 05/24/2024
• Device Model Number: C0H12
• Device Catalogue Number: 101474194
• Device Lot Number: 1417586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1