MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC CLEARIFY VISUALIZATION SYSTEM; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number 21345

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Date 05/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report sent on 06/16/2015 under mfr report# 2647580-2015-00446.The initial mdr was sent with the incorrect manufacturing site in error.The mdr was resubmitted under 3006462610-2015-00003 with the correct manufacturing information.Subsequently, the (b)(4) was made inactive due to transfer of product to the ponce manufacturing plant.Report resubmitted under 2647580-2015-00650 with active cfn number.

Event Description

Procedure: laparoscopic sigmoid colectomy.According to the reporter: clearify visualization system ((b)(4)) wand tip broke off during a laparoscopic sigmoid colectomy.The tip was not found.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.Delay in surgery? no (i.E.An extension of the hospital stay, infection, etc.?) 9.What is the current status of the patient? pt.Expired not related to device 10.Can you confirm that the device will be returned for evaluation? unknown where the device goes after sent to medsun 11.Was the device reprocessed or re-sterilized prior to use? no 12.Did you experience any issue with the endopath xcel trocar or was just used in the same procedure? no if so, please describe any problems with the trocar.Additional information requested via email from (b)(6) the medwatch form stated that the lot number was p5a0380x but the response below states that the lot number is j0814hx.I will update the file accordingly with the appropriate lot number and that should be the last piece of information i need.Account confirmed that lot number is actually j0814hx.

• Brand Name: CLEARIFY VISUALIZATION SYSTEM
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5078114
• MDR Text Key: 26515519
• Report Number: 2647580-2015-00650
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Device Lot Number: J0814HX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR