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 2016-05-24 for STORZ INSTRUMENT ET1088TS manufactured by Bausch + Lomb.
[45773635]
The product has been requested for evaluation however it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[45773636]
During surgery the tip of the clamp is broken in two in the patient eye. The piece has been removed from the eye. No clinical impact for the patient. Product requested. Patient okay.
Patient Sequence No: 1, Text Type: D, B5
[48568981]
The instrument was visually inspected under a microscope. There was no evidence of a material defect or a manufacturing error. The instrument is broken. One jaw of the instrument broke off. The instrument appeared as though it has not been cleaned. Unable to determine how or when this instrument broke.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001920664-2016-00173 |
| MDR Report Key | 5675712 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-24 |
| Date of Report | 2016-04-25 |
| Date Mfgr Received | 2016-06-20 |
| Date Added to Maude | 2016-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer G1 | ST. LOUIS |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ INSTRUMENT |
| Generic Name | CAPSULORHEXIS TIP SHORT |
| Product Code | HNY |
| Date Received | 2016-05-24 |
| Returned To Mfg | 2016-06-20 |
| Model Number | ET1088TS |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2016-05-24 |