MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE

Catalog Number 6268.NMD05

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).The investigation confirmed that there was a particle inside the tubing set.However we where not able to determine how or where this may have occurred.This may cause injury to the patient, hence it is reportable.The risk is foreign matter or particle.There is no information that reasonably suggests patient injury occurred.All available information has been disclosed.This complaint has now been closed.

Event Description

There is a stain on the blade.

• Brand Name: DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE
• Type of Device: DISPOSABLE PNEUMATIC VITRECTOME, 25 GAUGE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer (Section G): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer Contact: laura smith ; 10 continental dr; bldg 1; exeter, NH 03833 ; 6037786929
• MDR Report Key: 7621916
• MDR Text Key: 112449715
• Report Number: 1222074-2018-00194
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 6268.NMD05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1