MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. BACKFLUSH INSTRUMENT WITH 23 GAUGE / 0.6 MM BLUNT NEEDLE; VITRECTOMY FLUID/ GAS HANDLING INSTRUMENT

Catalog Number 2281.AD06

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.

Event Description

We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Please be informed that the investigation regarding this event is ongoing.

Manufacturer Narrative

In regard to this event one backflush instrument was received for investigation.Visual inspection of the returned instrument revealed cracks in the front cap.In fact, the cap was held together with tape.Close examination of the broken parts showed markings that were found consistent with damage that would be the result of an attempt to take the instrument apart; possibly with the intention of cleaning it for reuse.Device history record review revealed no deviations.It should be noted that all backflush instruments are visually inspected prior to being released for distribution.A database search showed that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, it was determined that the reported event is attributable to damage caused by an attempt to use the device more than once while it is designed for one use only as indicated on the product labelling.

Event Description

We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.

Event Description

We were informed that the shaft of the instrument came loose from the handle.No actual patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.Dhr review performed did not reveal any anomalies.Since it has been indicated that the product will be returned the investigation will be continued when the device is available for examination.

• Brand Name: BACKFLUSH INSTRUMENT WITH 23 GAUGE / 0.6 MM BLUNT NEEDLE
• Type of Device: VITRECTOMY FLUID/ GAS HANDLING INSTRUMENT
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 12452739
• MDR Text Key: 270814575
• Report Number: 1222074-2021-00064
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 2281.AD06
• Device Lot Number: 2000418746
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/19/2021; 11/23/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1