MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA DISPOSABLE HIGH SPEED TDC CUTTER 27 GAUGE / 8000 CPM DORC CONTINUUM RANGE; OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC

Catalog Number 8268.VIT27

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation will be initiated as soon as possible.

Event Description

During the procedure, a vitrectomy cutter suddenly came apart.The surgery was completed and no patient or operator harm occurred.

Event Description

During the procedure, a vitrectomy cutter suddenly came apart.The surgery was completed and no patient or operator harm occurred.

Manufacturer Narrative

With regards to this complaint, one 27 gauge disposable high speed tdc cutter was received for investigation.Visual inspection of the instrument revealed a crack in the body of the cutter.Device history record review revealed no deviations.According to a review of the complaint database, no similar complaints have been reported on this specific lot previously.Cracks in the body of the vitrectome are a confirmed occasional deficiency that is related to the current design.Though, plotted against the sales, the failure rate is relatively low, we very much regret this occurrence.Please note that actions are currently being taken towards the introduction of a vitrectome with a new and improved design that should prevent this type of failure.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 27 GAUGE / 8000 CPM DORC CONTINUUM RANGE
• Type of Device: OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 9807376
• MDR Text Key: 194510593
• Report Number: 1222074-2020-00017
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8268.VIT27
• Device Lot Number: 2000376174
• Patient Sequence Number: 1