MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE

Catalog Number	8268.VIT23
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2015
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 after disassembly on the surface of the back of the inner-knife is some glue.This caused the leakage we have discussed this with the production team.Since bubbles are creating due to glue presence in the inner cutter, there is harm to the patient.Hence it is concluded as reportable.The associated risk is injury by microbial, viral or prion infection (patient harm) , therefore upon retrospective review, this complaint was identified as reportable.The complaint is confirmed.All available information has been disclosed.The complaint has now been closed.
Event or Problem Description
This is to report you that we have a bubbling issue with 8268.Vit.Occured at the beginning of the surgery with higher cut rate.Sample is available.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE
• Common Device Name: DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 8000 CPM DORC CONTINUUM RANGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7507270
• Report Number: 1222074-2018-00118
• Device Sequence Number: 13816268
• Product Code: HQE
• UDI-Device Identifier: 08717872020792
• UDI-Public: 08717872020792
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2015

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.VIT23
• Device Lot Number: 2000365461
• 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: 07/29/2015
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1