MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for DISP 23G TROCAR SYSTEM, STERIL 1272.EDPP6 manufactured by Dutch Opthalmic Research Center Bv.
[105900128]
Found foreign particle in cannula tip, there is a possibility of using the cannula, 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. All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[105900129]
A report from (b)(6) has been received. The following has been reported: a piece of plastic (probably from the production process) at the tip of the trocar. The customer gave the particle to his microbiology. No further information. All information has been disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00072 |
| MDR Report Key | 7430800 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-02-10 |
| Date of Event | 2018-02-10 |
| Date Mfgr Received | 2015-02-10 |
| Date Added to Maude | 2018-04-13 |
| 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 BLDG 1 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISP 23G TROCAR SYSTEM, STERIL |
| Generic Name | DISP 23G TROCAR SYSTEM, STERIL |
| Product Code | NGY |
| Date Received | 2018-04-13 |
| Catalog Number | 1272.EDPP6 |
| Lot Number | 2000365241 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |