MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL EVA VITRECTOMY PACK VGPC INPUT 23G

Catalog Number	8300.23G02
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident has occurred during surgery, formation of bubbles during surgery might lead to patient harm.Hence this complaint is concluded as reportable.This is reportable because of the bubble issue while using vitrectome.Performance varies in- and out-of-specification.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer.Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.All available information has been provided.
Event or Problem Description
A report has been received from (b)(6) reporting several problems.The irrigation tubing was completely clamped.They replace the pack.The following problem occurred several times with the same pack.Bubbles with the vitrectome and infusion line.There is no sample as it was discarded.Information suggests that the event occurred during surgery and there is no information that the patient was harmed.

• Brand Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Common Device Name: EVA VITRECTOMY PACK VGPC INPUT 23G
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6950379
• Report Number: 1222074-2017-00018
• Device Sequence Number: 718386
• Product Code: HQE
• UDI-Device Identifier: 08717872019000
• UDI-Public: 08717872019000
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2014

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 Catalogue Number: 8300.23G02
• Device Lot Number: 2000362025
• 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: 04/22/2014
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1