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

Catalog Number 8523.210

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during core vitrectomy procedure, the trocar cannulas (valved, blue cap side) were leaking.Surgery could proceed by replacing the trocar cannulas.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Event Description

We have been informed that during core vitrectomy procedure, the trocar cannulas (valved, blue cap side) were leaking.Surgery could proceed by replacing the trocar cannulas.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 and a database search showed that no similar complaints have been reported on this specific lot.However, based on other similar complaints on other lots of this product a detailed investigation of the manufacturing process revealed that when 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.Subsequent to the investigation, the drying time was increased as a corrective action to prevent similar issues.Therefore, the most plausible rootcause of this complaint is considered a sticky valve due to insufficient drying time of glue in relation to the volume of glue applied.In 2022 an increase in complaint rate was observed, which triggered a detailed investigation of the manufacturing process.As a result the dry time will be increased, as this was considered the cause of the increase in complaints observed.Per ecf 2022-390, a change was initiated to increase the drying time between glue application and next steps of assembly.The change was implemented with an update of all relevant work instructions.As of (b)(6) 2022 all aveta trocars are assembled in accordance with the updated work instructions.The analysis includes all complaints with failure modes ci-closurevalve-leakage and ci-closurevalve-defect-removal related to comparable trocar systems.

• Brand Name: EVA CUSTOM 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; 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: 15743498
• MDR Text Key: 303160565
• Report Number: 1222074-2022-00081
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8523.210
• Device Lot Number: 2000429896
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1