MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF12, 5X100 KII FIOS ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF12
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	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: instrument guide dropped into the patients abdomen during surgery.By luck the assistance surgeon saw this and was able to retrieve the plastic instrument guide.Dkma report received via email on 14jan2020 (translation provided by territory manager): during a laparoscopic cholecystectomy discovered the assisting doctor a plastic piece laying loose inside the patients abdominal cavity between the intestines.The surgeon gets the plastic piece out and discover that it came from the trocar.It is a coincidence that plastic piece is found due to limited vision during a laparoscopic surgery the plastic piece could have disappeared between the intestines.Type of intervention: retrieval of separated part.Patient status:no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with the shield, a clear plastic component of the seal.Visual inspection of the event unit confirmed the complainant's experience of seal component separation.The septum, an internal rubber 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 reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical's instructions for use (ifu) 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.".
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: instrument guide dropped into the patients abdomen during surgery.By luck the assistance surgeon saw this and was able to retrieve the plastic instrument guide.Dkma report received via email on 14jan2020 (translation provided by territory manager): during a laparoscopic cholecystectomy discovered the assisting doctor a plastic piece laying loose inside the patients abdominal cavity between the intestines.The surgeon gets the plastic piece out and discover that it came from the trocar.It is a coincidence that plastic piece is found due to limited vision during a laparoscopic surgery the plastic piece could have disappeared between the intestines.Intervention: retrieval of separated part.Patient status: no patient injury.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9624211
• Report Number: 2027111-2020-00331
• Device Sequence Number: 14177569
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)221020(30)01(10)1368131
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 10/20/2022
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1368131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1