MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 23G CANNULA SET WITH HIGH FLOW INFUSION LINE; OPHTHALMIC CANNULATION SET, SINGLE-USE

Catalog Number 1272.ED23

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

It was reported that during the vitrectomy, bubbles came out of the trocar (valve).No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this complaint, three cannulas with closure valves were received for investigation.Visual inspection confirmed that the product had been used; however, no anomalies were detected.Testing revealed that the returned closure valves showed no signs of leakage.Since the valves met their specification (maximum water leakage of 0.4 ml/min at 40 mmhg), the reported failure could not be confirmed for the returned product.Based on the investigation performed, a remedial action/corrective action/preventive action/field safety corrective action (fsca) is not required.The analysis includes all complaints with failure modes ci-closurevalve-leakage and ci-closurevalve-defect-removal related to comparable trocar systems.

Event Description

It was reported that during the vitrectomy, bubbles came out of the trocar (valve).No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: 23G CANNULA SET WITH HIGH FLOW INFUSION LINE
• Type of Device: OPHTHALMIC CANNULATION SET, SINGLE-USE
• 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: 15541988
• MDR Text Key: 303243740
• Report Number: 1222074-2022-00071
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/14/2022

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: 1272.ED23
• Device Lot Number: 2999435377
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1