MAUDE Adverse Event Report: NIDEK CO., LTD. MK-2000; HAND PIECE NIDEK KERATOME

Model Number MK-2000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

Nidek received a complaint from customer on (b)(6)2013.Customer reported that one of the blade holders appeared to be cutting thicker during surgery with mk-2000; hand piece s/n (b)(4).There was no other information at the time.

Manufacturer Narrative

The affected device was returned to nidek for evaluation on 08/05/2013.Nidek service engineer (se) had conducted an evaluation and tested for proper operation.Service engineer found that some parts were deteriorated.The unit was out of specifications.The hand piece was repaired; o-ring and base was replaced, the hand piece was re-greased and re-aligned and tested for proper operation.The unit had returned back to the customer.Nidek contacted customer to gather additional information regarding the reported event and confirmed that there was no patient injury involved with the event reported; the patient did fine after the surgery.Nidek considers this failure mode a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.

• Brand Name: MK-2000
• Type of Device: HAND PIECE NIDEK KERATOME
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14. hiroishi; gamagori, aichi ; JA
• Manufacturer (Section G): NIDEK CO., LTD. HAMACHO PLANT; 34-14 hiroishi; gamagori, aichi 443- 0038; JA 443-0038
• Manufacturer Contact: neo yamaguchi ; 47651 westinghouse drive; fremont, CA 94539 ; 5105572550
• MDR Report Key: 4332731
• MDR Text Key: 5217788
• Report Number: 3002807715-2014-00018
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• PMA/PMN Number: K990900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MK-2000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1