MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO12, GELPOINT PATH 9CM; FER

Model Number 10

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.There is no report of serious injury or death associated with this event.

Event Description

Transanal mass incision - the seal from the gelpoint trocar sleeve was dislodged towards the end of the case.A storz needle driver and vlock suture were used within the sleeve.It was stated that the instruments were passed through the sleeve no more than 10 times and the manipulation of the instruments were not considered aggressive.The surgeon was able to retrieve the piece with no patient injury.Type of intervention - na.Patient status - no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon investigation, engineering confirmed that the shield, an internal component of the seal, had dislodged from one of the trocar sleeves.It is likely that an instrument caught on the shield during insertion and dislodged it from the trocar sleeve.The instructions for use (ifu) states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers", and "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: CNO12, GELPOINT PATH 9CM
• 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: 6544520
• MDR Text Key: 74427798
• Report Number: 2027111-2017-01764
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915124755
• UDI-Public: (01)00607915124755(17)180902(30)01(10)1253551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/02/2018
• Device Model Number: 10
• Device Catalogue Number: 10
• Device Lot Number: 1253551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Treatment: STORZ NEEDLE DRIVER, VLOCK SUTURE