MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON CLEARIFY VISUALIZATION SYSTEM; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number 21345

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter phone number: (b)(6).Contact office phone number: (b)(4).

Event Description

According to the reporter, during a gastric sleeve the trocar wipe of clarify was put down trocar and when it came out to end was shredded.Part of the trocar wipe fell into the patient and was retrieved with graspers.The last know status of the patient is reported as good.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one trocar wipe for a clarify visualization system and one photograph.Only the trocar wipe was received.A piece of the foam tip was missing.The photograph shows what may be the missing piece of foam in the patient cavity.Product analysis suggests the product was used in a surgical procedure.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.No enhancements or improvements were generated for the reported condition.Replication for the damaged foam tip may be related to rough handling of unit while cleaning the trocar.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: CLEARIFY VISUALIZATION SYSTEM
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven
• MDR Report Key: 6240375
• MDR Text Key: 64977054
• Report Number: 1219930-2017-00038
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1