MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-10-30 for DISPOSABLE VITRECTOMY CUTTER OPO39 manufactured by Abbott Medical Optics.
[3796458]
Surgeon was working a case on a dense cataract. He sculpted a central bowl and then introduced his chopper into the eye. After he made his first ''chop'', the lens ''tilted'', indicating perhaps, a one hundred eighty degree loss of zonular support. At that point, he withdrew the phaco handpiece from the eye. He then began working with two hand held instruments. At the point where he noticed vitreous had come around the lens, where he had lost zonular support, he called for the vitrector. The vitrector was set up in the usual way, utilizing a bimanual approach. The cutter head and the infusion cannula were submerged in a reservoir of balanced salt solution (bss) and the ''start vit prime'' button was pushed. Following that cycle, system was inserted into the eye. When surgeon began vitrecting, the aspiration level seemed low.
Patient Sequence No: 1, Text Type: D, B5
[11396725]
Phaco specialist (ps) and his manager were on site. When the surgeon re-entered the eye, there did not seem to be any aspiration at all. And ps advised the surgeon to withdraw the cutter. Ps then tested the aspiration. Then the ps had the technician re-submerge the cutter in the reservoir of bss and instructed surgeon to? Floor it? Without success. At that time, ps instructed the technician to join the irrigation/aspiration tubing together and reprimed the circuit. Following the successful reprime, the ps instructed the tech to reassemble the bimanual vitrectomy set up. After that was accomplished, ps instructed the technician to submerge the infusion cannula and cutter head into the reservoir again. Ps once more asked surgeon to ''floor it''. Fluid flow was observed in the collection bag and ps told surgeon the system was ready for use. When surgeon introduced the cutter back into the eye, aspiration was present but weak. After a review of the facts, it was determined that a back flush was necessary for the aspiration line of the cutter to work and or, change the cutter itself. Ps got out of room to request technical support and when he came back asked his manager, present also, if the vitrector had been used to remove the tissue, and he said it had. Surgeon? S final comments to me regarding this incident were as follows: ''i think that the cutter head became clogged with dried viscoelastic. When that blockage was cleared, the aspiration returned to normal. ''
Patient Sequence No: 1, Text Type: N, H10
[16246496]
Surgeon reported that he believes the vitrector cutter stopped only because the tubing got plugged with viscoelastic necessitating change of the tubing pack. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[21577948]
(b)(4). All pertinent information available to abbott medical optics at this time has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[23394004]
Expiration date was not provided in initial and supplements due to lot number is unknown. In initial report,? No? Was selected for health professional, however the initial reporter is a physician and health professional should be selected as? Yes?. For follow-up #2, the date received by manufacturer was not provided. The correct date is 8/27/2014. Device manufacturer date in initial and supplements was not provided as to lot number is unknown. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[27003438]
In initial report, model# was selected as unknown however the model no is opo39. Lot# was provided but it was not found since customer provided the incorrect lot no and product is disposable. Lot number is unknown. In initial report, serial# was provided, however the product does not have serialized product but only lot no. And lot no. Is unknown. Device available for evaluation was selected "yes" in the initial report however, the suspected product is disposable and unable to obtain. Device available for evaluation should have been selected "no" in initial report, labeled for single use was selected as "no" however it has been corrected to reflect "yes" in this supplement. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020664-2013-00104 |
| MDR Report Key | 3438739 |
| Report Source | 05,07 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-01 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2014-10-02 |
| Date Added to Maude | 2013-10-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | ROAD 402 NORTH, KM 4.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE VITRECTOMY CUTTER |
| Generic Name | DISPOSABLE VITRECTOMY CUTTER |
| Product Code | MLZ |
| Date Received | 2013-10-30 |
| Model Number | OPO39 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-30 |