MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA TDC VITRECTOMY PACK VGPC INPUT 23G; SURGICAL PACKS AND KITS

Catalog Number 8310.23G12

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

We have been informed that the surgeon experienced leakage of the closure valve during vitrectomy and combined vitrectomy procedure.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

Unfortunately, since the involved trocar was not returned, no physical examination could be performed.Device history record review revealed no deviations.A database search showed that no similar complaints have been reported on this specific lot previously.Please note that, due to a recent increase of closure valve related complaints on the aveta trocar, a broader investigation was initiated.A detailed investigation of the manufacturing process revealed that when in the manufacturing process the drying time of the applied glue on the cap of the product is too short for the volume of glue dispensed, valves may in some cases become sticky.As a result of the investigation the drying time of glue was increased to prevent re-occurrence of this malfunction going forward.

Event Description

We have been informed that the surgeon experienced leakage of the closure valve during vitrectomy and combined vitrectomy procedure.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 23G
• Type of Device: SURGICAL PACKS AND KITS
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuiland, 3214V-N ; NL 3214VN
• MDR Report Key: 15851446
• MDR Text Key: 304307835
• Report Number: 1222074-2022-00084
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8310.23G12
• Device Lot Number: 2000429129
• Is the Reporter a Health Professional?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1