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	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that the part that connects the tubing to the vitrectome was broken and the outer knife was in a angle.The investigation regarding the air bubbles could not be done due to the broken part.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) this reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(4) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
During operation, air bubble happened.Situation is as follows; eva shaving mode, 8000cpm, flow:ss, vaccume 600.Please investigate it carefully and find root cause, and improve.Sample is available.

• 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: 7518018
• Report Number: 1222074-2018-00134
• Device Sequence Number: 16526065
• Product Code: HQE
• UDI-Device Identifier: 08717872020808
• UDI-Public: 08717872020808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/21/2015

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
• Operator of Device: Physician
• Device Catalogue Number: 8268.VIT25
• Device Lot Number: 2000371167
• 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: 10/21/2015
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1