MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for SYNERGETICS ENDO-OCULAR LASER PROBE 55.36.25E manufactured by Bausch + Lomb.
[76413534]
The doctor provided a video of the procedure where a piece of the laser probe became detached. The video shows the laser extended in the eye and the laser not getting much uptake. The laser was retracted and the focus gets a little fuzzy then there was a small brown line near the macula. The doctor used a soft tip cannula to pull it out and it is clearer outside the eye. The complaint sample was returned for evaluation in a biohazard bag on (b)(6) 2017. The portion of the probe which broke was the front (distal) end of the fiber; approximately 3/32? In length. It was examined under magnification while in the bag. The polished end of the fiber (distal end) was visible with no damage evident while the other end was visibly blackened. There was no fiber visible under magnification in the nitinol tube, suggesting that the crack or break in the fiber occurred inside the metal nitinol tube. Value stream manufacturing engineer, value stream line supervisor and qa reviewed this piece under 22x magnification during a (b)(6) 2017 meeting and indicated that they had not previously seen a break pattern like this one on the 150-micron fiber design; the previous 200-micron fiber design was more rigid and did have a breakage issue. This is considered an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
[76413535]
While using the laser probe during surgery a piece detached in the patients eye. The patient was not harmed and the doctor was able to retrieve the piece that broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2017-00005 |
| MDR Report Key | 6600720 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 636226-322 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DR |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYNERGETICS ENDO-OCULAR LASER PROBE |
| Generic Name | PHOTOCOAGULATOR AND ACCESSORIES |
| Product Code | HQB |
| Date Received | 2017-05-31 |
| Returned To Mfg | 2017-05-09 |
| Model Number | 55.36.25E |
| Lot Number | M429120 |
| ID Number | NI |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |