MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR33, 11X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR33
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic adrenalectomy.Event description: air seal part inside of the handle was separated from the trocar into patience abdominal cavity during the surgery.Luckily it was detected by surgeon and taken out from the patient body.Additional information was received via email from country manager, 7-jan-2019: it seems torn parts fall into patient's abdominal cavity and luckily surgeon identifies parts and removed safely.The fall parts are both white and black.Additional information was received via email from country manager, 7-jan-2019: the incident happened once.Surgeon is just comparing what is normal one and tried to show what happened.He asked nurse to open a new device.Intervention: detected by surgeon and taken out from the patient body.Patient status: normal.
Additional 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, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrument 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 or Problem Description
Procedure performed: laparoscopic adrenalectomy.Event description: air seal part inside of the handle was separated from the trocar into patience abdominal cavity during the surgery.Luckily it was detected by surgeon and taken out from the patient body.Additional information was received via email from country manager, 7jan2019 it seems torn parts fall into patient' abdominal cavity and luckily surgeon identifies parts and removed safely.The fall parts are both white and black.Additional information was received via email from country manager, 7jan2019 the incident happened once.Surgeon is just comparing what is normal one and tried to show what happened.He asked nurse to open a new device.Intervention: detected by surgeon and taken out from the patient body.Patient status: normal.

• Brand Name: CTR33, 11X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8267988
• Report Number: 2027111-2019-00325
• Device Sequence Number: 2370286
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)210410(30)01(10)1321587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 04/10/2021
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1321587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1