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 2016-09-30 for LEICA M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.
[55988467]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation. Further investigation is required to determine if the device may have caused or contributed to the serious injury.
Patient Sequence No: 1, Text Type: N, H10
[55988468]
Leica microsystems (b)(4) received a complaint on (b)(6) 2016 from (b)(6) stating that the surgeon suspects the high temperature of leica m530 oh6 surgical microscope xenon lamp is the root cause that allegedly caused a patient (pt-2-jp) to go blind after neurosurgery. Further investigation is required to determine if the device may have caused or contributed to the serious injury.
Patient Sequence No: 1, Text Type: D, B5
[117020617]
This is a final report. Investigations have been conducted by the specification developer. The actual device was evaluated and there is no indication that the device is not functioning as expected. A review of the manufacturing and production records of the affected was also performed. Based on the results, all tested parameters as required in the records were within specification. The complaint database was also reviewed and there was no similar or identical complaints indicating a blindness or damage to the eyesight in any of the complaints. In addition, a simulated use testing was conducted. Furthermore, clinical experts were questioned/interviewed to evaluate if the alleged complaint can be confirmed. Based on the result of the simulated use testing and the interview with the clinical experts, it is unlikely that the heat from the surgical microscope illumination could cause damage to the optical nerve as alleged by the complainant. Based on the results of various investigations, the alleged complaint cannot be confirmed. Therefore, it can be concluded that the affected device operated within specification and that the affected device did not contribute or cause to the adverse event (loss of vision).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2016-00011 |
| MDR Report Key | 5989707 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-09-21 |
| Date Mfgr Received | 2016-09-23 |
| Device Manufacturer Date | 2015-10-08 |
| Date Added to Maude | 2016-09-30 |
| 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 | MR. ROLAND JEHLE |
| Manufacturer Street | MAX SCHMIDHEINY STRASSE 201 |
| Manufacturer City | HEERBRUGG, ST. GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer Phone | 717263216 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 608924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M530 OH6 |
| Generic Name | LEICA M530 OH6 |
| Product Code | EPT |
| Date Received | 2016-09-30 |
| Model Number | M530 OH6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX SCHMIDHEINY STRASSE 201 HEERBRUGG, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-09-30 |