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	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent 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
Hand assisted laparoscopic hemicolectomy - "during the procedure the doctor felt something hard in the abdominal cavity.He looked around and found a clear piece of plastic which turned out to be the instrument seal from the trocar.The trocar in question was placed in the upper left quadrent of the abdomen during the procedure.The doctor was able to remove the piece of plastic from the abdomen.Laparoscopic graspers and a cotton swab were the only instruments inserted into the trocar." "the entire seal came out." patient status - "the patient is fine, there was no complications with them from this incident." type of intervention - "the doctor was able to remove the piece of plastic from the abdomen.".
Additional Manufacturer Narrative
Investigation summary: the event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed that the shield, a clear internal component of the seal, had been dislodged and was damaged.Fragmentation was also observed on the septum, an internal rubber component of the seal.The likely root cause of the dislodged shield and damage to the seal components is an instrument.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: 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: 6042423
• Report Number: 2027111-2016-00701
• Device Sequence Number: 18851369
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)190323(30)01(10)1267067
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/22/2017

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: 03/23/2019
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1267067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC GRASPERS, COTTON SWAB