MAUDE Adverse Event Report: MORIA INC. MORIA PUNCH D8.00 MM; PUNCH, CORNEO-SCLERAL

Model Number D8.00 MM

Device Problems Failure to Cut (2587); Defective Device (2588)

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

Event Date 05/10/2019

Event Type  malfunction  

Event Description

After surgeon cut the donor tissue, it was noted that tissue was not completely cut making tissue not usable for surgery.While inspecting the punch, a defect was noted on the blade.The second stage of surgery was delayed due to need for new tissue from eye bank.The eye incision sutured closed until new tissue arrived.

• Brand Name: MORIA PUNCH D8.00 MM
• Type of Device: PUNCH, CORNEO-SCLERAL
• Manufacturer (Section D): MORIA INC.; 1050 crosskeys drive; 1050 cross keys dr.; doylestown PA 18901
• MDR Report Key: 9165941
• MDR Text Key: 161542778
• Report Number: 9165941
• Device Sequence Number: 1
• Product Code: HNJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019,09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D8.00 MM
• Device Catalogue Number: 17200D800
• Device Lot Number: 1190209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA