FDA Adverse Event Malfunction Summary report: N

DISPOSABLE HIGH SPEED TDC CUTTER 27 GAUGE / 8000 CPM DORC CONTINUUM RANGE

MDR report key: 9807376 · Received March 9, 2020

Report

Report Number: 1222074-2020-00017
Event Type: Malfunction
Date Received: March 9, 2020
Manufacturer: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
Product Code: HQE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

DURING THE PROCEDURE, A VITRECTOMY CUTTER SUDDENLY CAME APART. THE SURGERY WAS COMPLETED AND NO PATIENT OR OPERATOR HARM OCCURRED.

Additional Manufacturer Narrative · 1

INVESTIGATION WILL BE INITIATED AS SOON AS POSSIBLE.

Description of Event or Problem · 1

DURING THE PROCEDURE, A VITRECTOMY CUTTER SUDDENLY CAME APART. THE SURGERY WAS COMPLETED AND NO PATIENT OR OPERATOR HARM OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
272721	DISPOSABLE HIGH SPEED TDC CUTTER 27 GAUGE / 8000 CPM DORC CONTINUUM RANGE	OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC	HQE	D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA		2000376174

Patients

Seq	Age	Sex	Outcome	Treatment
1