MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CLEARIFY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 21-345

Device Problem Product Quality Problem (1506)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the scrub nurse pressed the power button of the first device and the bottom or the cardboard covering came off and exposed the batteries.The second device was opened and the bottom or cardboard came off, but it did not expose the batteries.The third device was opened and worked fine.The surgeon never used it and the patient was never involved, this was all on the back table.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8202666
• MDR Text Key: 131608082
• Report Number: 9612501-2018-02306
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 40884521213563
• UDI-Public: 40884521213563
• Combination Product (y/n): N
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 21-345
• Device Catalogue Number: 21-345
• Device Lot Number: D8F2279X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1