MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX; GCJ

Model Number	CFB12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: cystectomy laparoscopy.Event description: during a laparoscopy with dr., a gas leak in the trocar was found during the procedure.The surgeon therefore changed his trocar, the intervention was able to continue, but the operating team realized that part of the previous trocars fell into the abdomen.It seems to me that it is a seal, which would explain this leak.The pharmacist think it is the seal.Additional information received from the sales rep by email on 23apr19: this is the first seal.The part of the trocar that fell in the abdomen was retrieved from the patient.An entire component fell out.2 photos are attached to the complaint.Type of intervention: change of device.Patient status: ok.
Event or Problem Description
Procedure performed: kystectomy laparoscopy.Event description: during a laparoscopy with dr.[name], a gas leak in the trocar was found during the procedure.The surgeon therefore changed his trocar, the intervention was able to continue, but the operating team realized that part of the previous trocars fell into the abdomen.It seems to me that it is a seal, which would explain this leak.The pharmacist think it is the seal.Additional information received from the sales rep by email on 23apr19: this is the first seal the part of the trocar that fell in the abdomen was retrieved from the patient.An entire component fell out.2 photos are attached to the complaint.Additional information received from the sales rep by email on 25apr19: date of incident was 18apr19 type of intervention: change of device.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation without the shield, a plastic internal component of the seal.However, a photograph of the dislodged shield was provided, which showed that shield had been damaged.Visual inspection confirmed the complainant's experience of seal component separation.The septum, a rubber internal component of the seal, was torn.Based on the condition of the returned unit and the description of the event, it is likely that the torn septum and the seal component separation were 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.".

• Brand Name: CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8603775
• Report Number: 2027111-2019-00448
• Device Sequence Number: 2359051
• Product Code: GCJ
• UDI-Device Identifier: 00607915124106
• UDI-Public: (01)00607915124106(17)211101(30)01(10)1341045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 11/01/2021
• Device Model Number: CFB12
• Device Catalogue Number: 101452701
• Device Lot Number: 1341045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHARP INSTRUMENT, GRASPER, MONOPOLAR