MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-12-17 for USA ELITE SYSTEM M3 AUTOCL. FOROBLIQUE SCOPE M3-30A manufactured by Gyrus Acmi, Inc..
[1514630]
The surgeon was using an m3-gold autoclavable foroblique telescope during a turf procedure, he complained that there was no proper visualization. He was not using a camera. The surgeon aborted the case mid-way through the procedure. He went to place the catheter and realized that it was not seated properly. When he took off the drapes, he noticed that the pt's abdomen was distorted. The surgeon opened the pt and found that the bladder had been perforated. The pt spent some time in the icu, but has since been sent home. A loop and a dac cord were also used in the procedure, but were discarded by the facility.
Patient Sequence No: 1, Text Type: D, B5
[8322915]
A visual examination of the scope revealed severe burn marks and excessive heat discoloration at the distal tip. The stainless steel outer tube has been severely melted in two different locations and the light fibers have been damaged at those same locations and the light fibers have been damaged at those same locations. It is also noted that moisture can be seen in the lens train using a 10x eye loupe. The distal window is chipped at 12 o'clock position when viewing from distal end and the light post up. The image is noted as cloudy due to internal damage to the telescope, likely due to overheating. Light output is at 8. 11%, well below the required 22%. Damage appears to be user error. Repair is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2009-00033 |
| MDR Report Key | 1565285 |
| Report Source | 07 |
| Date Received | 2009-12-17 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-11-10 |
| Date Facility Aware | 2009-11-10 |
| Date Mfgr Received | 2009-11-17 |
| Device Manufacturer Date | 2009-01-08 |
| Date Added to Maude | 2010-09-29 |
| 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 | 3 |
| Manufacturer Contact | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 93 NORTH PLEASANT ST. |
| Manufacturer City | NORWALK OH 44857 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE SYSTEM M3 AUTOCL. FOROBLIQUE SCOPE |
| Generic Name | AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Product Code | FBP |
| Date Received | 2009-12-17 |
| Returned To Mfg | 2009-12-14 |
| Model Number | M3-30A |
| Catalog Number | M3-30A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-17 |