MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM

Catalog Number	1281.BTD05
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is foreign material attached on the shaft part.The investigation showed that the foreign object on the shaft is glue.This will be reviewed with the production department to find out how this has escaped the attention of the quality control.During the retrospective review, and as per the complaint description, foreign material may lead to serious harm to patient, hence concluded as reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.No information reasonably suggests anyone was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
There is foreign material attached on the shaft part.No report of injury.All information has been disclosed.

• Brand Name: BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM
• Common Device Name: BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7531331
• Report Number: 1222074-2018-00141
• Device Sequence Number: 11082069
• Product Code: HQR
• UDI-Device Identifier: 08717872003870
• UDI-Public: 08717872003870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2015

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 Catalogue Number: 1281.BTD05
• Device Lot Number: 2000371247
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2015
• Initial Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1