MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-16 for SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G 3269.SBS05 manufactured by Dutch Opthalmic Research Center Bv.
[108900404]
The investigation showed that when the fiber is inserted several times this kind of fracture is not possible. The investigation showed that the outside layer of the fiber is torn apart. This is not a production related error. This is a user error. Assuming worst case during surgery, the shaft tip got broken several times when the surgeon inserting the instrument into the patient's eye. This may cause a severe harm in the eye of the patient. Hence considered reportable. There is no information reasonably suggesting that the patient was harmed. 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)(4) during a tele-conference on (b)(4) 2017. All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[108900405]
During operation, the doctor inserted this instrument into a patient's eye several times. And then, the shaft tip part got broken. No further information is available. All information has been disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00135 |
| MDR Report Key | 7520326 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-16 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-10-22 |
| Date Mfgr Received | 2015-10-22 |
| Date Added to Maude | 2018-05-16 |
| 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 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 | 3 |
| Brand Name | SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G |
| Generic Name | SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G |
| Product Code | MPA |
| Date Received | 2018-05-16 |
| Catalog Number | 3269.SBS05 |
| Lot Number | 2000369609 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-16 |