MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV EVA VITRECTOMY PACK VGPC INPUT 25G

Catalog Number	8300.25G02
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history lot review: there was nothing relative to the complaint.This lot met the specifications outlined for release.Sample analysis: no sample was returned.Conclusion: there is no evidence of any manufacturing issues that would result in a tip detachment.This is likely an isolated incident.We are unable to confirm since no sample was received.(b)(4).All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received of an incident that occurred in france.During surgery, the tip detached from the handle before the end of the surgery.And during the surgery, there was a time with no light at all.There is no available information on the status of the patient therefore we assume no patient injury.

• Brand Name: EVA VITRECTOMY PACK VGPC INPUT 25G
• Common Device Name: EVA VITRECTOMY PACK VGPC INPUT 25G
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• MDR Report Key: 7345626
• Report Number: 1222074-2018-00051
• Device Sequence Number: 1325561
• Product Code: HQE
• UDI-Device Identifier: 08717872019024
• UDI-Public: 08717872019024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/03/2015

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
• Operator of Device: Physician
• Device Expiration Date: 12/15/2015
• Device Catalogue Number: 8300.25G02
• Device Lot Number: 2000366916
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2015
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1