MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: "lap jejunostomy tube placement." event description: this is the explanation from dr.About the problem he encountered: "5 mm trocar with a loose plastic particle, when inserted into the patient loose particle was in patient's abdomen.Seen with laparoscopic camera and removed immediately by surgeon.No harm to patient.Surgeon requested report to manufacturer notified of incident.Safety report completed.Trocar packaged and given to materials management staff to follow up with manufacturer.Type of intervention: "removed immediately by surgeon." patient status: "no harm to patient.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of the loose plastic particulate.Scratches were also observed on the inner surface of the cannula.Based on the condition of the returned unit, it is likely that the particulate was generated by contact with an instrument during instrument exchange through the cannula.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.

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7028321
• Report Number: 2027111-2017-02111
• Device Sequence Number: 19155677
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)200621(30)01(10)1298751
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: Other
• Device Expiration Date: 06/21/2020
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1298751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1