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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
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: tepp.Event description: during inflation, the balloon burst again and even a part of it lay in the extraperitoneal space.The bellows were operated for about 10-15 times.The patient was not harmed.Intervention: retrieval of separated part.Patient status: the patient was not harmed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a fragment.Visual inspection confirmed the complainant¿s experience of balloon fragmentation.The balloon material was stretched, torn, and fragmented.The fragment was identified to be from the balloon.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the exact root cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: tepp.Event description: during inflation, the balloon burst again and even a part of it lay in the extraperitoneal space.The bellows were operated for about 10-15 times.The patient was not harmed.Additional information received from applied medical representative via email on 29-nov-2021: customer always uses a 0 degree scope for inguinal hernia repairs.Manufacturer [ ], 10mm diameter.Representative has tested this and inflated the balloon 40 times and has tried to damage the balloon with the scope several times.This did not work.He also verified if the scope became hot, this was not the case either.Intervention: retrieval of separated part.Patient status: the patient was not harmed.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12708418
• Report Number: 2027111-2021-00694
• Device Sequence Number: 1467762
• Product Code: GCJ
• UDI-Device Identifier: 00607915137229
• UDI-Public: (01)00607915137229(17)240701(30)01(10)1420946
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: C0H12
• Device Catalogue Number: 101474194
• Device Lot Number: 1420946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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: 0 DEGREE SCOPE. MANUFACTURER KARL STORZ, 10MM
• Patient Sex: Unknown