MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM

Catalog Number	8267.VIT20
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that when there is aspiration is ( too) low the vitrectome spits bubbles.However when the aspiration is normal is bubbles are gone.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) there is no information reasonably suggesting that the patient was harmed.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)(6) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
The vitrectoom spits air according to the customer.Sample available.No ill effect to patient reported.All information has been disclosed.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 20G/8000CPM
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7520691
• Report Number: 1222074-2018-00136
• Device Sequence Number: 1529419
• Product Code: HQE
• UDI-Device Identifier: 08717872019109
• UDI-Public: 08717872019109
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2015

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: 8267.VIT20
• Device Lot Number: 2000371564
• 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: 11/02/2015
• 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