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

Catalog Number 8310.27G02

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

We were informed that prior to use, foreign material was noticed in the packaging.Therefore, the product was not used.No patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.

Manufacturer Narrative

In regard to this complaint, an open 27-gauge eva tdc vitrectomy pack with vgpc input was received for investigation.Visual inspection confirmed the presence of a white crystalline substance on various products in the pack, especially on the vitrectome tray and between the body and the cap of the vitrectome.The substance was also detected on the cartridge and in the cutter's aspiration tube and connector.Further examination showed that the white crystalline substance is consistent with salt residue from evaporated balanced salt solution (bss).Based on the investigation results, it was concluded that one or more materials from the pack had been used or that a considerable amount of bss unintendedly ended up in the already opened blister.Hence, the reported failure could not be attributed to the product itself or its manufacture.Investigation revealed the root cause is not product or manufacturing related, but has external reasons.Therefore, risk assessments were not reviewed.

Event Description

We were informed that prior to use, foreign material was noticed in the packaging.Therefore, the product was not used.No patient harm occurred.

• Brand Name: EVA TDC VITRECTOMY PACK
• 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: 15425556
• MDR Text Key: 302721205
• Report Number: 1222074-2022-00063
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8310.27G02
• Device Lot Number: 2000429602
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1