MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 27G CANNULA SET WITH HIGH FLOW INFUSION LINE; DORC TROCAR SYSTEM,

Catalog Number 1272.ED27

Device Problem Material Fragmentation (1261)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

We have been informed that during posterior surgery, when removing the cannula, the metal part broke and fell outside the operative area.There is no report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during posterior surgery, when removing the cannula, the metal part broke and fell outside the operative area.There is no report of patient/user harm.No report of prolonged or delayed surgery.

Manufacturer Narrative

In regard to this complaint, one broken cannula was received.The capillary that is situated beneath the yellow ring had broken off.The funnel above the ring appeared to be missing.Close examination showed deformation of the capillary at the breaking point, suggesting that the capillary itself was grabbed with pliers or forceps, rather than the yellow ring.Though the observed deformation may have caused the break, it might just have occurred when the broken capillary was removed from the eye after breaking.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on any lot previously.Based on the investigation performed, the cause of failure could not be determined.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.

• Brand Name: 27G CANNULA SET WITH HIGH FLOW INFUSION LINE
• Type of Device: DORC TROCAR SYSTEM,
• 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: 15331689
• MDR Text Key: 305363142
• Report Number: 1222074-2022-00059
• Device Sequence Number: 1
• Product Code: HQC
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1272.ED27
• Device Lot Number: 2000431226
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1