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

Model Number CNO11

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

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

Tamis - "transparent instrument protector fell into rectal space during procedure.Instruments used was 10mm 30dg, attraumatic grasper and minopolar diathermy needle electrode.Both angled tem instruments.We discussed the happening after surgery where we concluded that the needle electrode may be the cause of incident.The device is taken care of at the department for pickup.No life threatening situation occured and the instrument protector was easy detected and removed from space." patient status - "no life threatening situation occured".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation along with a dislodged instrument shield, an inner component of one of the trocars.Upon investigation, engineering observed scratch marks on the instrument shield, indicating that it had come into contact with an instrument.The root cause of the damage to the instrument shield is contact with an angled instrument.Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if additional information is obtained 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: 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: 6174386
• MDR Text Key: 62380612
• Report Number: 2027111-2016-00885
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915124755
• UDI-Public: (01)00607915124755(17)171130(30)01(10)1235809
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2017
• Device Model Number: CNO11
• Device Catalogue Number: 101351501
• Device Lot Number: 1235809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10MM 30DG, ATTRAUMATIC GRASPER; MINOPOLAR DIATHERMY NEEDLE ELECTRODE