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	07/30/2015
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 cap inside, by the chamber for the o-ring is cracked.The chamber for the o-ring and the plastic part for fixating the o-ring was too tight.We have corrected this problem.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 to you that we have a bubbling issue with 8267.Vit.Occured at the beginning of the surgery with higher cut rate.Sample is available.

• 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: 7508099
• Report Number: 1222074-2018-00119
• Device Sequence Number: 19403597
• Product Code: HQE
• UDI-Device Identifier: 08717872019086
• UDI-Public: 08717872019086
• 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): 07/30/2015

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: 2000358003
• 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: 07/30/2015
• 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