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

Catalog Number	8267.VIT25
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation showed that the o- ring , the stainless steel ring and the plastic ring are not straight against the body.Therefore the seal between the o-ring and the inner knife can not be guaranteed to be closed.Since instrument producing air bubbles, it leads to harm the patient.Hence it is concluded as reportable.Assuming worst case during surgery 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 that patient harm had occurred.All available information has been disclosed.The complaint is confirmed and has now been closed.
Event or Problem Description
Does not suck well and spits air.All information has been disclosed.Sample available.No report of patient injury.

• Brand Name: DISPOSABLE HIGH SPEED CUTTER 25G/8000CPM
• Common Device Name: DISPOSABLE HIGH SPEED CUTTER 25G/8000CPM
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7504436
• Report Number: 1222074-2018-00113
• Device Sequence Number: 13495010
• Product Code: HQE
• UDI-Device Identifier: 08717872019086
• UDI-Public: 08717872019086
• 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): 07/08/2015

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.VIT25
• Device Lot Number: 2000368217
• 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: 07/08/2015
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1