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

Catalog Number	8268.VIT25
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A report has been received from (b)(6) reporting small piece of metal from vitrector fell down on the retina during vitrectomy.It looked like the part of internal guillotine.The surgery was completed with an equivalent device/pack.There is no indication of an injury or that any medical intervention had occurred due to the event.A sample is available for evaluation.A supplemental will be submitted when investigation is complete.
Additional Manufacturer Narrative
The device has been received and the investigation has started.Investigation shows that the bridge of the inner knife is completely broken off.The reason for breaking could be that the inner knife is too long and bumps into the front of the outer knife, the bridge bends and eventually breaks.More investigation is needed to find out what happened exactly with the vitrectome concerned.A supplemental will be submitted when the investigation is complete.
Additional Manufacturer Narrative
Examination of the returned cutter revealed that the outer knife was bent.Further investigation showed that the inner knife was broken.The damage observed was related to the length of the inner knife relative to the length of the outer knife.When the inner knife is too long, it hits the front cap of the outer knife until it finally breaks.Damage due to incorrect measurements is considered a manufacturing related failure.The risk management file for this product family includes consideration of this failure mode(deviation from production process).Although harm may be associated with this failure, no patient harm occurred in this instance.All cutters supplied by dorc are 100% tested prior to shipment to verify cutting efficacy (which by definition precludes a broken knife) - in this case it appears therefore that the cutter failed during use.In a review of the complaints database (25th july 2018) no other incidents of components breaking away from vitrectomes and giving rise to metal particles in the eye were identified.The probability of occurrence of harm associated with this failure mode is 1, which is improbable.Given that to date only one incident of this issue with no patient harm has occurred in more than 430,000 instruments sold the last three years, the risk / benefit of this product is considered by dorc to be consistent with the risk management file.Furthermore, review of the complaint database revealed no similar complaints on the lot.Section 2.16 in en iso 14971:2012: risk = combination of the probability of occurrence of harm and the severity of that harm.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
• Common Device Name: DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; p.o. box 43; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7403607
• Report Number: 1222074-2018-00066
• Device Sequence Number: 1054806
• Product Code: HQE
• UDI-Device Identifier: 08717872020808
• UDI-Public: 08717872020808
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Followup,Followup
• Report Date (Section B): 07/26/2018

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 Catalogue Number: 8268.VIT25
• Device Lot Number: 2000390260
• 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: 03/28/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 07/26/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/27/2018; 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1