MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R83, 12X60 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R83
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: esophagectomy.Event description: during an esophagectomy they used these 2 trocars and they found a little peace of rubber in the thorax.The collected the peace of rubber.The customer wants to know if this peace of rubber came from the seals of 1 of the trocars or was a piece of residual rubber from production.There where no patient injuries or complications.Additional info received by phone on december 11 from the tm when taking the complaint that it is not known if the piece of rubber is from one of the trocars.Type of intervention: n/a.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.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 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.

• Brand Name: C0R83, 12X60 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: 7170473
• Report Number: 2027111-2018-00008
• Device Sequence Number: 1826452
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)200705(30)01(10)1300851
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/24/2018

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: 07/05/2020
• Device Model Number: C0R83
• Device Catalogue Number: 101218501
• Device Lot Number: 1300851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1