MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR72,12X150 KII OPT ZTHR HDL 6/BX; GCJ

Model Number	CTR72
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.There is no report of serious injury or death associated with this event.
Event or Problem Description
Partial gastrectomy- "use of obturator 12 x 150 mm.Defect on the seal tightness reflux: tear and small pieces detached from the dm.We found them inside the patient abdomen.Apparently this is not the first time.There was no loss of pneumoperitoneum.Device not available for evaluation.No pictures available." additional information received 13 july 2016: instruments used during surgery and before incident were grasper (reusable) and ligasure 5x44.Moreover, the surgeon has introduced a compress inside abdomen.Type of intervention: "surgeon has removed the small pieces successfully from the abdomen.Small pieces are black color.Surgeon used another device to continue the procedure." patient status: "ok".
Additional Manufacturer Narrative
The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the exact root cause of the incident could not be confirmed, the engineering evaluation revealed that the likely root cause may be due to damage caused by an instrument.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.

• Brand Name: CTR72,12X150 KII OPT ZTHR HDL 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5828230
• Report Number: 2027111-2016-00544
• Device Sequence Number: 13502800
• Product Code: GCJ
• UDI-Device Identifier: 00607915125059
• UDI-Public: (01)00607915125059(17)181217(30)01(10)1260710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060096
• 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): 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/17/2018
• Device Model Number: CTR72
• Device Catalogue Number: 101063701
• Device Lot Number: 1260710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 09/26/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention