MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-20 for CYSTOTOME * E-141-2S manufactured by Bausch & Lomb.
[19463839]
Black particulate flaking from bausch & lomb ophthalmic instruments: irrigation cannula, straight cannula, polisher, & cystotome. Particulate removed from surgical site via microscopic visualization. Response from bausch & lomb indicated that some lots of instrument hubs were manufactured with a thinner than usual brass coating on the nickel hub. Instrument hubs deteriorated with proper sterilization technique. Dates of use #1: 3 1/2 years; #2: 3 1/2 years. Diagnosis or reason for use #1: instrumentation, #2: instrumentation. Event abated after use stopped: #1: yes; #2: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005968 |
| MDR Report Key | 1017532 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-20 |
| Date of Event | 2007-09-11 |
| Date Added to Maude | 2008-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOTOME |
| Generic Name | CYSTOTOME |
| Product Code | HNY |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-15 |
| Model Number | * |
| Catalog Number | E-141-2S |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 986518 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 3365 TREE COURT INDUSTR. BLVD ST. LOUIS MO 63122 US |
| Brand Name | POLISHER |
| Generic Name | POLISHER |
| Product Code | HMF |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-15 |
| Catalog Number | E508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 986519 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 3365 TREE COURT INDUSTR. BLVD LOUIS MO 63122 US |
| Brand Name | IRRIGATION CANNULA |
| Generic Name | IRRIGATION CANNULA |
| Product Code | HMX |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-15 |
| Catalog Number | E4922 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 3 |
| Device Event Key | 986520 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 3365 TREE COURT INDUSTR. BLVD LOUIS MO 63122 US |
| Brand Name | STRAIGHT CANNULA |
| Generic Name | STRAIGHT CANNULA |
| Product Code | HMX |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-15 |
| Catalog Number | E499-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 4 |
| Device Event Key | 986521 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 3365 TREE COURT INDUST. BLVD LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-03-20 |