MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX; GCJ

Model Number C0R47

Device Problems Material Fragmentation (1261); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation along with a rubber fragment and the shield, a clear plastic internal component of seal.Visual inspection confirmed the complainant's experience of seal component separation.The rubber fragment completed the missing portion of the septum, a rubber component of the seal.Based on the condition of the returned unit and the description of the event, the loss of pneumoperitoneum resulted from the seal component separation, which was likely caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.Applied medical¿s instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: digestive surgery.Event description: loss of pneumoperitoneum during instrument change in open trocar.From the latter was detached in the patient's abdomen, 2 detached parts, recovered by the surgeon before the end of the procedure.Observed and possible consequences: infectious risk and surgery.Additional information received from sales rep via email on 10jan2019: the incident occured in (b)(6) 2018, the medical team of [] does not remember details surrounding the incident.It is unknown what part of the seal detached.It is unknown the color of the detached component.It is unknown if an entire component fell out or torn off.It is unknown the instrumentation that was being used at the time of the incident.There is no consequence on patient.The name of the procedure is digestive surgery.The device is available and has been returned.Replacement is requested.C0r47 is the model involved with this cer.Patient status: no consequence on patient.

• Brand Name: C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 8376354
• MDR Text Key: 138816072
• Report Number: 2027111-2019-00363
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453(17)201207(30)01(10)1311881
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: C0R47
• Device Catalogue Number: 101246101
• Device Lot Number: 1311881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1