MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA TDC VITRECTOMY PACK VGPC INPUT 25G; SURGICAL PACKS AND KITS

Catalog Number 8310.25G12

Device Problem Material Fragmentation (1261)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that during vitrectomy procedure it was noticed that particulate matter was released from vitrectome and entered the eye.The particles were immediately and successfully removed.No patient harm or prolongation of the surgery occurred due to this event.

Manufacturer Narrative

The complaint is under investigation.

Manufacturer Narrative

In regard to this complaint, one 25 gauge disposable high speed tdc cutter was returned for investigation.The particle that was detected in the eye of the patient was not received.Since the particle was not received, inspection and testing to determine its origin were not possible.Thorough examination of the cutter revealed no anomalies; the cap at the distal end of the outer knife as well as the bridge and welds of the inner knife appeared to be completely intact.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, the origin of the particle could not be determined.The particle may have originated from any (metal) instrument that was used during the operation, but we cannot exclude the possibility that it did in fact originate from the cutter.Hence, the investigation findings did not lead to a clear conclusion concerning the cause of the reported adverse event.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.Since the reported adverse event cannot be attributed to the dorc cutter, further remedial/corrective/fsc actions are deemed not required.

Event Description

It was reported that during vitrectomy procedure it was noticed that particulate matter was released from vitrectome and entered the eye.The particals were immediately and successfully removed.No patient harm or prolongation of the surgery occurred due to this event.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 25G
• 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: 14100938
• MDR Text Key: 290063712
• Report Number: 1222074-2022-00030
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8310.25G12
• Device Lot Number: 2000429590
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1