MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; GCJ

Model Number C0R37

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Note: the incident date occurred during the week 30 of this year (2016) there is no report of serious injury or death associated with this event.

Event Description

Sleeve gastrectomy: "i would like to inform you that you will receive from (b)(6) regarding the trocar c0r37: i had a call from ms (b)(6) (in charge of medical devices in (b)(6)) regarding a potential dysfunction of the trocar cor37 it would appear that the introduction of the obturator is difficult and remove the seal during his introduction." doctor (b)(6) was the user of the device.The incident was observed during placement of the obturator inside the cannula.Type of intervention: "the surgeon had used another trocar." patient status: "did a patient injury or illness occur associated with the complaint (yes or no) she said us: no.".

Manufacturer Narrative

Full udi# provided.October 06, 2016: customer informed us that they didn't keep the unit.Additional information was requested from the customer and provided.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 root cause of the experience could not be determined, applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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: C0R37, 15X100 KII OPT ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5890368
• MDR Text Key: 52615694
• Report Number: 2027111-2016-00590
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1264195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1