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

Catalog Number 8300.23G12

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during vitrectomy procedure, the closure valve was leaking.No report that actual patient harm occurred or surgery was prolonged 30 min.

Manufacturer Narrative

In regard to this complaint, two cannula's with closure valves were received for investigation.Visual inspection revealed minor damage to one of the valves.The other was in pristine shape.Physical testing showed that both closure valves met the maximum water leakage specification of 0.4 ml/min at 40 mmhg.In fact, the valves only started to leak at respectively 140 mmhg and 257 mmhg pressure.Based on the investigation performed, a product failure could not be confirmed for the returned closure valves.Based on the investigation performed, a remedial action/corrective action/preventive action/field safety corrective action (fsca) is not required as the complaint could not be reproduced on the actual product.The analysis includes all complaints with failure modes ci-closurevalve-leakage and ci-closurevalve-defect-removal related to comparable trocar systems.

Event Description

We have been informed that during vitrectomy procedure, the closure valve was leaking.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: EVA 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: 15713326
• MDR Text Key: 307113752
• Report Number: 1222074-2022-00080
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8300.23G12
• Device Lot Number: 2000435905
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1