MAUDE Adverse Event Report: MORIA; PUNCH D9.00MM

Model Number PUNCH D9.00MM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

Patient was having a penetrating keratoplasty procedure done.The donor cornea was being prepared on the back table.The surgeon and scrub tech were using the moria punch d9.00mm, (b)(4), lot 1141905 to cut the cornea.After cutting the cornea, the syringe on the punch was pushed and the cornea flew off of the donor punch.The surgeon, scrub tech, circulator and crna all tried to locate the cornea but were unable to find it.No incision on the patient was made.No adverse affect to patient.The case was cancelled by surgeon.

• Type of Device: PUNCH D9.00MM
• Manufacturer (Section D): MORIA; antony 92160 ; FR 92160
• MDR Report Key: 4692492
• MDR Text Key: 5672968
• Report Number: MW5042079
• Device Sequence Number: 1
• Product Code: HNJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PUNCH D9.00MM
• Device Catalogue Number: 17200D900
• Device Lot Number: 1141905
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 27