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

Catalog Number 8523.210

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complaint article was received by d.O.R.C.Investigation will be initiated as soon as possible.

Event Description

During a procedure, after a fluid/air exchange step, air bubbles were leaking from all ports hindering a surgeon's view.According to the surgeon, the air bubbles were escaping from valves of trocars.The procedure was completed, as it was close to the end.Patient's harm did not occur.

Manufacturer Narrative

With regard to this complaint, three cannulas with closure valves were received for investigation.Review of the batch record did not reveal any anomalies.Microscopic examination of the closure valves revealed that one of the closure valves was damaged.The damaged observed is consistent with unintended damage of the closure valve which can occur when an instrument or infusion line is inserted or retracted (e.G.Damage by the vitrectome when removing a vitrectome from the eye while cutting, inserting the infusion line in an oblique angle).During functional testing all closure valves met the release specifications regarding maximum leakage.Hence, based upon the investigation performed it is concluded that although one of the closure valves was damaged during surgery, the reported event is not attributable to the device.

Event Description

During a procedure, after a fluid/air exchange step, air bubbles were leaking from all ports hindering a surgeon's view.According to the surgeon, the air bubbles were escaping from valves of trocars.The procedure was completed, as it was close to the end.Patient's harm did not occur.

• 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 (INTERNA; scheijdelveqeg 2; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 9900855
• MDR Text Key: 199736375
• Report Number: 1222074-2020-00033
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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: No Information
• Device Catalogue Number: 8523.210
• Device Lot Number: 2000405946
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2020
• Patient Sequence Number: 1