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 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information received.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.There is no report of serious injury or death associated with this event.

Event Description

Lap assisted trans anal protectomy- "gpp set up all standard with no issues.General use with no issues in and out with graspers and monopolar hook.When 3-0 v loc on a lap needle holder inserted through (now damaged) sleeve noticed fluid collection and needed to suction, rather than leave the needle in the access channel mr (b)(6) pulled the needle back into the sleeves seal housing while he inserted the suction through the other sleeve.When he tried to push the v loc back through the seal housing back into the access channel we noticed the instrument guide had become.Detached and pushed through the seal housing into the access channel.Mr (b)(6) cut the v loc sutur and removed the damaged port.Replaced with a new sleeve, tried to remove the v loc through the new sleeve but wouldn't come out, therefore keeping hold of the v loc with the needle holder removed the v loc and port from the gel all together.Took the gel seal cap off to reinsert the sleeve using the introducer and continued the operation.Upon visual inspection with (b)(6) the scrub nurse the tip of the v lock was bent at a right angle and was catching on the edge of the sleeve when trying to pull through the sleeve (hence why we had to remove the sleeve entirely to get the suture out." additional information received from applied medical team member via email 24oct2016: the seal housing consists of three elements, a plastic instrument guide, the instrument seal then the double duck bill seal.It is the plastic "fringe" type element which became detached.Under visual inspection, i couldn't see that any of the seal components had become detached, just the plastic instrument guide.Patient status - no patient injury or illness associated with the event.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering confirmed that the plastic shield was dislodged from one of the trocar sleeves.The most likely root cause of the trocar shield dislodgement is the insertion of an angular or bent instrument.The instructions for use (ifu), warns that "extra care should be used when inserting angular and asymmetrical instruments." all instruments should be centered axially when inserted through the shield to prevent dislodgement.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 the initial 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: 6088084
• MDR Text Key: 59465689
• Report Number: 2027111-2016-00756
• Device Sequence Number: 1
• Product Code: FER
• 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
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CNO11
• Device Catalogue Number: 101471791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1