MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE

Catalog Number	8268.VIT25
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After careful analysis it was concluded to be a design related issue.Our r&d department is using this regretful circumstance to continuously improve our products.We are sorry for the inconvenience caused.Please accept our sincere apologies.Assuming worst case during surgery, air bubbles observed at the probe.This may cause injury to the patient.Hence it is reportable.The risk is possible injury by microbial, viral or prion infection (patient harm).Also it is possible for a piece to end up in the eye.In this event the patient did have what was described as "a little conjunctiva hemorrhage" and no information reasonably suggests it needed intervention or further treatment.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4) centre (b)(4)).(b)(6).All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A demo was being performed.The procedure was a retinal detachment.The surgeon practiced a core vitrectomy and went to peripheral vitrectomy.Settings 2500 to 7000cpm , flow mode 350mmhg 0->3.5 cc/mn when suddenly, bubbles came out of the vitrectomy needle.The surgeon was asked to retrieve and check the vitrectomy in a cup and when she was about to re insert the needle in the eye, the vitrectomy burst out in two parts, the cap in one part, and the vit on the other.When you carefully look at the vitrectomy it seems there no glue or seal system on it.The patient has not been wounded but a little conjunctiva hemorrhage, but we were close.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
• Common Device Name: DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7537770
• Report Number: 1222074-2018-00148
• Device Sequence Number: 16738307
• Product Code: HQE
• UDI-Device Identifier: 08717872020808
• UDI-Public: 08717872020808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/11/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 8268.VIT25
• Device Lot Number: 2000362148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2016
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention