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

Model Number MK-2000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

Nidek received a complaint from a customer on (b)(6) 2014.Customer reported that during the surgery on (b)(6) 2014 with mk-2000 hand piece s/n: (b)(4) a free flap occurred with 130um blade holder and 9.5mm suction ring on patient's first eye.The second eye was done with a 160um blade holder and 9.5 suction ring.The second flap was fine.There was no other information provided at the time.

Manufacturer Narrative

Nidek contacted the customer to do follow up on (b)(6) 2014; dr.(b)(6) reported that the free flap patient looked good with healed abrasion and 20/25+ va.Temporal edge of flap was slightly rough so a new bandage contact lens was put in.The patient's dose for durezol was decreased to bid.Patient was on moxeza qid and ats q2h.On (b)(4) 2014 nidek director of sales and marketing called back again to check the patient's status and talked to the nurse and confirmed that the patient did fine with 20/20 va.Nidek contacted the facility again on (b)(4) 2014 to make sure that the patient recovered well and did not develop any adverse events due to the free flap.The affected device was returned to nidek for evaluation on 03/28/2014.Nidek service engineer (se) had conducted an evaluation and tested for proper operation.Service engineer found that the height size was out of specification for blade holder s/no: (b)(4).She also checked the other two blade holders s/no: (b)(4) which were within specifications.Hand piece has been operational with blade holders s/n (b)(4) and not with s/no: (b)(4).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: HANDPIECE NIDEK KERATOME
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14, hiroishi; gamagori, aichi
• Manufacturer (Section G): NIDEK CO., LTD.; 34-14, hiroishi; gamagori, aichi 443- 0038; JA 443-0038
• Manufacturer Contact: neo yamaguchi ; 47651 westinghouse dr.; fremont, CA 94539 ; 5105572550
• MDR Report Key: 4188887
• MDR Text Key: 5091626
• Report Number: 3002807715-2014-00020
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2014

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: 03/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• 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