MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-22 for DMEK SINSKEY HOOK UP 50.2201 manufactured by D.o.r.c Dutch Ophthalmic International Bv.
[100723371]
We have investigated the instrument. The tip of the instrument is broken. It is unknown when or where the tip broke, if during use or during transport we shall not know. No further information on the outcome of the patient. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)). This event was reported due to an event of hypotony. Assuming worst case during surgery, air bubbles observed at the probe. This may cause injury to the patient. Hence it is reportable. The risk is possible injury by microbial, viral or prion infection (patient harm).
Patient Sequence No: 1, Text Type: N, H10
[100723372]
A report was received of an incident that occurred in (b)(6). The following incident was reported : "it seems there is a little hole (valve) in the tube which is connecting the handpiece. Our client thinks it should not be there because the anterior chamber collapsed twice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00043 |
| MDR Report Key | 7290082 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-22 |
| Date of Report | 2014-11-27 |
| Date of Event | 2014-11-27 |
| Date Mfgr Received | 2014-11-27 |
| Date Added to Maude | 2018-02-22 |
| 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 |
| 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 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DMEK SINSKEY HOOK UP |
| Generic Name | DMEK SINSKEY HOOK UP |
| Product Code | HNQ |
| Date Received | 2018-02-22 |
| Catalog Number | 50.2201 |
| Lot Number | 2000364482 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-22 |