MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-17 for KARL STORZ 628002 manufactured by Karl Storz Gmbh & Co. Kg.
[2638460]
Allegedly, the tip of the sickle knife broke off in the pt's nasal passage during an ent procedure; the tip fell down the pt's throat. The doctor performed a laryngoscopy and retrieved the piece with a grasper. He went on to complete original procedure; only a minor delay caused and there was no impact on pt. Pt condition post op was good.
Patient Sequence No: 1, Text Type: D, B5
[9885203]
The tip of the knife is broken off; it is approximately 7mm in length. Contact at hospital stated they believed it broke due to the density and hardness of the septum bone. Condition of instrument is consistent with damage caused by mechanical overload. This is the only report of breakage of this instrument that we have received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2012-00016 |
| MDR Report Key | 2588426 |
| Report Source | 06 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-05-15 |
| Date of Event | 2012-04-17 |
| Date Facility Aware | 2012-04-17 |
| Report Date | 2012-05-15 |
| Date Reported to FDA | 2012-05-15 |
| Date Reported to Mfgr | 2012-05-15 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2012-08-07 |
| 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 Street | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, POSTFACH 230 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | SICKLE KNIFE |
| Product Code | KTG |
| Date Received | 2012-05-17 |
| Returned To Mfg | 2012-05-01 |
| Model Number | 628002 |
| Catalog Number | 628002 |
| Lot Number | BI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-17 |