MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-03-21 for PNEUMATIC HIGH SPEED CUTTER, MAX. 6000 CUTS/MIN 25G/0.5 MM. (BOX/6, STERILE) 6267.NMD05 manufactured by D.o.r.c Dutch Ophthalmic International Bv.
[103151404]
This problem is known. We have adapted the vitrectoom body, making it no more tears, so that no air can come in vitrectoom as that is what causes bubbles. 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) 2017. Upon review of this incident, bubbles formed from the cutter may possibly lead to patient harm. Therefore this complaint is concluded as reportable. Assuming worst case air bubbles observed at the probe, may cause injury to the patient. Hence it is reportable. The risk is possbile injury by microbial, viral or prion infection (patient harm) all available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[103151405]
A report has been received from (b)(6) on the following incident: when the doctor was using the cutter with connecting to the ust at operation, air bubbles suddenly came out from the cutter tip part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00047 |
| MDR Report Key | 7359145 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-03-21 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-09 |
| Date Added to Maude | 2018-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037538824 |
| Manufacturer G1 | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, NETHERLANDS |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMATIC HIGH SPEED CUTTER, MAX. 6000 CUTS/MIN 25G/0.5 MM. (BOX/6, STERILE) |
| Generic Name | PNEUMATIC HIGH SPEED CUTTER |
| Product Code | MLZ |
| Date Received | 2018-03-21 |
| Catalog Number | 6267.NMD05 |
| Lot Number | 2000364775 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-21 |