MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF74, KII 12X100 FIOS Z-THR HN 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF74
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	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: (translation): the trocar seal dislodged in the patient's abdomen.No clinical consequences.Recovery of the seal in the patient's abdomen.Removal of the device.Use of a new trocar.Type of intervention: component removed, change of device.Patient status: no clinical consequences.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal and was damaged.Engineering also observed that the septum, an internal rubber component of the seal, was fragmented.Based on the condition of the returned unit, 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: unknown.Event description: (translation): the trocar seal dislodged in the patient's abdomen.No clinical consequences.Recovery of the seal in the patient's abdomen.Removal of the device.Use of a new trocar.Intervention: component removed, change of device.Patient status: no clinical consequences.

• Brand Name: CTF74, KII 12X100 FIOS Z-THR HN 6/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: 9777259
• Report Number: 2027111-2020-00398
• Device Sequence Number: 1866361
• Product Code: GCJ
• UDI-Device Identifier: 00607915123710
• UDI-Public: (01)00607915123710(17)220917(30)01(10)1369715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/30/2020

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: 09/17/2022
• Device Model Number: CTF74
• Device Catalogue Number: 101470925
• Device Lot Number: 1369715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1