MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for STIFF 25GA SHIELDED WIDE 56.21.25PS manufactured by Bausch + Lomb.
[91901374]
The sterilization and lot history records were reviewed and found to be acceptable.
Patient Sequence No: 1, Text Type: N, H10
[91901375]
The user facility reported during a procedure for dacrocystorhinotomy (dcr) the drill came in contact with the light pipe and broke off about a half inch. Documentation review revealed a 25 gauge light pipe was passed through the superior punctum and through the canalicular system to a hard stop. The inside of the ipsilateral nasal cavity was inspected and the glow of the light pipe was appreciated in the anatomically expected area. The straight shot drill using a 20 degree angled diamond burr was then used to create an approximately 1 cm diameter osteotomy through the periosteum and bone, and the area over the glow light pipe just superior to the middle turbinate down to the lacrimal sac. The light pipe was removed from the lacrimal system for repositioning and it was noted that the distal approximately 2 cm were missing. It was felt that the instrument was not retained in the nasal cavity as the osteomy had not been completed and the patient was not visualized in the nose. The surgery continued with a second light pipe. A search was reported to be done in side nose, in drapes, on floor, in suction, and x-rays were taken. X-rays showed it was not present in the nose. Item not found in drapes, on the floor and not in suction containers. Suction containers were strained and nothing found. On (b)(6) 2017 the patient presented to surgeon? S office for scheduled follow up and reported she developed double vision when looking to the right following original surgery. A ct scan was ordered and showed a radiopaque foreign body that appeared to be in the left lacrimal system. The ct also suggested disinsertion of the left medial rectus muscle with transection. On (b)(6) 2017 the patient was taken for surgical procedure of? Incision of left nasolacrimal canalicular system with removal of foreign body. Plastic repair of left nasolacrimal canalicular system with stent, and left anterior orbitotomy with exploration of left medial rectus muscle.? No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001932402-2017-00010 |
| MDR Report Key | 7026289 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-06-14 |
| Date Added to Maude | 2017-11-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 6362263220 |
| Manufacturer G1 | SYNERGEITICS |
| Manufacturer Street | 3848 CORPORATE CENTRE DR. |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STIFF 25GA SHIELDED WIDE |
| Generic Name | ENDOILLUMINATOR |
| Product Code | MPA |
| Date Received | 2017-11-13 |
| Model Number | 56.21.25PS |
| Lot Number | M0009944 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-11-13 |