MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R50
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: cholecystectomy.Procedure performed: [translation]: balloon does not inflate.We took a new trocar.Beginning of intervention, no clinical consequences.Additional information received by email from applied medical representative on 2-dec-21: name of procedure being performed: cholecystectomy.Date of incident: (b)(6) 2021.The balloon malfunction was noticed before use.There was no damage to the balloon or the balloon inflation port.This was not a robotic case.Metal retractors were used.No sharp instrument come into contact with the balloon.Type of intervention: change of device.Patient status: no clinical consequences.
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: cholecystectomy.Procedure performed: [translation]: balloon does not inflate.We took a new trocar.Beginning of intervention, no clinical consequences.Additional information received by email from applied medical representative on 2-dec-2021: name of procedure being performed: cholecystectomy.Date of incident: (b)(6) 2021.The balloon malfunction was noticed before use.There was no damage to the balloon or the balloon inflation port.This was not a robotic case.Metal retractors were used.No sharp instrument come into contact with the balloon.Type of intervention: change of device.Patient status: no clinical consequences.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of balloon leakage.Upon closer inspection, the distal glue line was separated from the cannula and fragmented.Based on the condition of the returned unit, the balloon leakage was due to distal glue separation, likely caused by a weak bond to the cannula.However, the exact root cause of distal glue fragmentation is unknown.Based upon the initial description of the event, the event of balloon leakage is not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical has determined that this event is reportable due to the glue line fragmentation.
Event or Problem Description
Procedure performed: cholecystectomy.Procedure performed: [translation]: balloon does not inflate.We took a new trocar.Beginning of intervention no clinical consequences additional information received by email from applied medical representative on (b)(6) 2021: name of procedure being performed: cholecystectomy.Date of incident: (b)(6) 2021.The balloon malfunction was noticed before use.There was no damage to the balloon or the balloon inflation port.This was not a robotic case.Metal retractors were used.No sharp instrument come into contact with the balloon.Intervention: change of device.Patient status: no clinical consequences.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/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: 13052503
• Report Number: 2027111-2021-00786
• Device Sequence Number: 17115726
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)240830(30)01(10)1420397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060629
• 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): 01/27/2022

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: 08/30/2024
• Device Model Number: C0R50
• Device Catalogue Number: 101473806
• Device Lot Number: 1420397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: METAL RETRACTORS.
• Patient Sex: Prefer Not To Disclose