MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE PNEUMATIC VITRECTOME.(25 GAUGE / 0.5 MM)(WORKING WITH 30 P.S.I., MAX

Catalog Number	6267.NMD05
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that the cap was not against on the body, the fixation plate was not straight on the inner-knife and the spring was not straight in the body.This is a production error.R&d is in the process of a redesign for the vitrectome during the retrospective review, and as per the complaint description, 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).(b)(4).No information reasonably suggests anyone was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
The doctor used this cutter with ust for vitreous surgery.During use, air bubbles came out from the cutter tip part.Sample available.All information has been disclosed.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME.(25 GAUGE / 0.5 MM)(WORKING WITH 30 P.S.I., MAX
• Common Device Name: DISPOSABLE PNEUMATIC VITRECTOME.(25 GAUGE / 0.5 MM)(WORKING WITH 30 P.S.I., MAX
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7531519
• Report Number: 1222074-2018-00142
• Device Sequence Number: 156966
• Product Code: HQC
• UDI-Device Identifier: 08717872001401
• UDI-Public: 08717872001401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2015

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: 6267.NMD05
• Device Lot Number: 2000366214
• 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: 12/03/2015
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1