MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV PHACO EMULSIFICATION HANDPIECE

Model Number	3002.P
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has started.A supplemental will be submitted when any new information is received.
Event or Problem Description
The event occurred in (b)(6).We received a report of the following: irrigation pressure wasn't enough so during surgery the eye collapsed several times.Tried to rinse the hand piece with pressure to loosen the blockage, but that did not help.The procedure was completed with a different device/pack.
Additional Manufacturer Narrative
Investigation is started.Follow up: investigation is not completed yet.So far it was found that the alleged blockage could be confirmed when a cannula was inserted into the irrigation port.For further examination, the hand piece was sent to the initial manufacturer and particles were sent to a research agency for a material investigation to determine the origin of the particles.D.O.R.C.Did not yet receive the investigation results.
Additional Manufacturer Narrative
Examination of the returned phaco hand piece revealed that the irrigation port of the instrument was obstructed by a metal particle that did not originate from the instrument itself.Although the particle could originate from the phaco needle or another instrument used during surgery, it could also originate from residues present during the cleaning procedure.The particle was removed and the instrument was tested and found to be functioning in a proper manner.The hand piece will be returned to the customer.Review of the complaint database revealed that no similar complaints have been reported to dorc previously.

• Brand Name: PHACO EMULSIFICATION HANDPIECE
• Common Device Name: PHACO EMULSIFICATION HANDPIECE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; p.o. box 43; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7392784
• Report Number: 1222074-2018-00064
• Device Sequence Number: 13879352
• Product Code: HQC
• UDI-Device Identifier: 08717872008851
• UDI-Public: 08717872008851
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2018

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 Model Number: 3002.P
• 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: 03/21/2018
• Supplement Date Received by Manufacturer: 05/20/2018; 08/13/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/24/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1