MAUDE Adverse Event Report: AMR 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	05/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Laparoscopic gastrectomy: "the layers in the trocar tearing due to the stapler during procedures.Customer didn't want to have our feedback.Cer submission has been delayed because (b)(6) sales manager changed their account.The product was replaced with (b)(6) stock." patient status - "there was no patient injury because they change the product right after they found out defect.".
Additional Manufacturer Narrative
Evaluation summary: the event unit was returned for evaluation.Upon visual inspection, the fragmented septum was identified along with the particulate.The particulate did match the missing portion in the septum.During the manufacturing process, all trocars are thoroughly inspected and tested for functionality and performance prior to packaging.The damage to the septum appears to have been caused by an instrument.There is always a potential to tear or dislodge the internal seal components with multiple passes of instruments, especially with sharp or angular devices.The instructions for use (ifu) warns that "extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C0R83, 12X60 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5749462
• Report Number: 2027111-2016-00475
• Device Sequence Number: 4891
• Product Code: GCJ
• UDI-Device Identifier: 00607915116668
• UDI-Public: (01)00607915116668(17)190217(30)01(10)1265627
• Combination Product (Y/N): N
• 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): 01/12/2017

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: 02/17/2019
• Device Model Number: C0R83
• Device Catalogue Number: 101218501
• Device Lot Number: 1265627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1