MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA TDC VITRECTOMY PACK VGPC INPUT 25G; SURGICAL PACKS AND KITS

Catalog Number 8310.25G12

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.

Event Description

We were informed that particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.

Manufacturer Narrative

The complaint article was received for investigation.Visual inspection confirmed the foreign material as described in the reported event.As the origin of the material could not be clearly determined within d.O.R.C., the product will be analyzed in a external laboratory.As soon as results are available, the root cause investigation will be continued.

Manufacturer Narrative

In regard to this case, three cannula's from a disposable one step cannula system were received for investigation.Visual inspection confirmed the presence of a white substance on three cannula's and one inserter.Since the origin of the substance could not be determined within dorc, the product was sent to sgs laboratory in belgium for forensic analysis.Ftir reflection analyses revealed that the white substance was in fact precipitated vapor from the glue that is used during product assembly.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 an human error during quality control.Please note that actions have been taken to prevent re-occurrence of the reported event in the future.The risks and mitigations associated with the reported issue are identified in existing risk documents and no new risks were identified as part of this investigation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.

Event Description

We were informed that particles/stains were noticed on the valve and the inserter of the trocar set included in the procedure pack.No patient harm or prolongation of the surgery occurred due to this event.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 25G
• Type of Device: SURGICAL PACKS AND KITS
• 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: 13061170
• MDR Text Key: 282628165
• Report Number: 1222074-2021-00097
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

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: 8310.25G12
• Device Lot Number: 2000424624
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2021; 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1