MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of 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.
Event or Problem Description
Lap chole - "while performing lap chole, the surgeon noticed, after inserting scissors into the trocar, slivers of plastic consistent with the same colors of the trocar cannula.The slivers of plastic were removed during the procedure.Also included a new pair of scissor inserts that were used as well as pictures of the slivers, specimen, and trocar used during procedure." patient status - ok.

• Brand Name: CTB33, 11X100 KII SH BLD ZTHR 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 5704699
• Report Number: 2027111-2016-00440
• Device Sequence Number: 3745079
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)190224(30)01(10)1265813
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2016

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: 02/24/2019
• Device Model Number: CTB33
• Device Catalogue Number: 101219501
• Device Lot Number: 1265813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 06/07/2016
• Date Device Manufactured: 02/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown