MAUDE Adverse Event Report: US SURGICAL PUERTO RICO CLEARIFY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 21-345

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, pre-operatively, the bottom of the device fell off when putting the laparoscope into the warming hub.Another device was used.There was no patient involvement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the device noted no abnormalities to the foam body.The valve was opened.The surfactant was acceptable.The bottom panel was received, adhesive was present on the bottom panel.There is some adhesive present on the foam bottom.The device was received with the internal components falling out the bottom of the foam body.The black wire was broken from the battery pack.The condition of the device prevented a functional evaluation.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A cross functional team has reviewed the risk and rate of occurrence for this failure and has determined that no corrective actions are warranted at this time.However, the manufacturing line was relocated to another site.The controls are in place to prevent this type of condition from reoccurring.Additionally, the investigation detected a unreported condition of broken wire that has no relationship to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLEARIFY
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9520710
• MDR Text Key: 172816136
• Report Number: 2647580-2019-06326
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521213562
• UDI-Public: 10884521213562
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: P8J1154X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• 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