MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM; FER

Model Number CNO11

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.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 Description

"the inner black seal out of the trocar came away and was found inside the cannula whilst in the patient.The trocar was equally spaced from one another and not too close to the outer ring.The entire seal popped out.The reason was because the surgeon used a 'swap on a stick', to clean and wipe the seal of blood so the camera wouldn't get dirty on reintroduction, and inadvertently pushed too deep and pushed the black seal out." intervention - "it was retrieved safely." patient status - "fine.".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.Based on the description of the complainant's experience, the seal dislodgement was caused by the surgeon when a swab on a stick was used to clean the internal seal.The swab was inadvertently pushed too deep into the trocar and pushed the seal out.This could occur if the swab was inserted at an angle instead of axially.The instructions for use (ifu) states that "all instruments should be centered axially when inserted through the seal." 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: CNO11, GELPOINT PATH 5.5CM
• Type of Device: FER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5989418
• MDR Text Key: 55998988
• Report Number: 2027111-2016-00624
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915124755
• UDI-Public: (01)00607915124755(17)190414(30)01(10)1268347
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K133393
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/14/2019
• Device Model Number: CNO11
• Device Catalogue Number: 101424301
• Device Lot Number: 1268347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1