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 Material Fragmentation (1261)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

We have been informed that during vitrectomy procedure, two small pieces of metal were spotted on the macula.The particles were successfully removed with another forceps.The surgeon indicates that the small particles could come from one of the instruments used.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Manufacturer Narrative

Though various products might have attributed to the complaint (cutter, forceps and light probe), none of them were returned for investigation.Also, the pieces of metal that were reportedly found on the retina were not shipped to dorc for examination.Unfortunately, without any of the involved instruments or the particles itself, further investigation as to the origin of the particles and is not possible.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on the involved lots prior to this case or since.The particles may have originated from any metal instrument that was used during the operation, but the possibility that they did in fact originate from one of the instruments listed above cannot be excluded.Hence, the investigation findings did not lead to a clear conclusion concerning the cause of the reported adverse event.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.Since the actual root cause of the reported adverse event could not identified, no remedial action/corrective action/preventive action/field safety corrective action (fsca) will be initiated at this point.The analysis above is limited to vitrectomes and includes all complaints with failure mode vi-metalpart and vi-metalpart-removed.Vitrectome distribution figures up to april 25 2023 are reflected.Please note that similar complaints have not been reported on either forceps or light probe.

Event Description

We have been informed that during vitrectomy procedure, two small pieces of metal were spotted on the macula.The particles were successfully removed with another forceps.The surgeon indicates that the small particles could come from one of the instruments used.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16663027
• MDR Text Key: 313037975
• Report Number: 1222074-2023-00033
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1