MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-10 for INTER-TIP I/A TIP WITH HANDLE IH90303 W/IH90300 DP9704 TIP W/DP9701 HANDLE manufactured by Micro-surgical Technology, Inc..
[13845]
After surgery using this device, the pt suffered endophthalmitis. The cause is not known. Would like this instrument evaluated as a possible cause for this condition. The pt is recovering. Note: 8 handless and 8 i/a tips were returned for evaluation from these lot numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1995-00092 |
| MDR Report Key | 22009 |
| Date Received | 1995-03-10 |
| Date of Report | 1995-01-31 |
| Date of Event | 1995-01-10 |
| Date Facility Aware | 1995-01-18 |
| Report Date | 1995-01-31 |
| Date Reported to Mfgr | 1995-01-31 |
| Date Added to Maude | 1995-05-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTER-TIP I/A TIP WITH HANDLE |
| Generic Name | IRRIIGATION/ASPIRATION HANDPIECE |
| Product Code | HKP |
| Date Received | 1995-03-10 |
| Returned To Mfg | 1995-01-24 |
| Model Number | IH90303 W/IH90300 |
| Catalog Number | DP9704 TIP W/DP9701 HANDLE |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22098 |
| Manufacturer | MICRO-SURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | 720 B 9TH AVENUE KIRKLAND WA 98033 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-03-10 |