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

Model Number CNO11

Device Problems Detachment Of Device Component (1104); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided 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 Description

Ta tme, practicing purse-string during ta tme workshop in lap-trainer in human colon- "during the purse-string exercise for ta tme at the ta tme workshop at (b)(6) center the delegate and faculty member spotted the plastic ring in the human colon ( in the lap-trainer) when they pulled the camera back.The plastic ring came out of the trocar that was used for a hand-instrument.The trocar has not been used for the scope." patient status: n/a.

Manufacturer Narrative

Investigation summary: one (1) 10mm trocar sleeve was returned for evaluation.Upon visual inspection, engineering confirmed that the shield was fully dislodged from the seal of the trocar.Upon further inspection, engineering disassembled the 10mm sleeve and found that the septum and duckbill were torn.Two tears were found near the bottom opening of the septum and one tear was found on the bottom edge of the duckbill.All gelpoint® minis undergo 100% visual inspection during the assembly and packaging process.The most likely root cause of the shield dislodging would be inserting an instrument non-axially into the sleeve.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 "extra care should be used when inserting angular and asymmetrical instruments.To minimize eversion of the sleeve's seal, instruments with high textured surfaces should be coated with a sterile lubricant." although the root cause of the event could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.Additional information requested and received.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 the supplemental report will be submitted to the fda.

• 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: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 5777499
• MDR Text Key: 49029953
• Report Number: 2027111-2016-00515
• Device Sequence Number: 1
• Product Code: FER
• UDI-Public: (01)00607915124755I(17)190302(30)01(10)1265864
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2019
• Device Model Number: CNO11
• Device Catalogue Number: 101424301
• Device Lot Number: 1265864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1