MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-22 for KARL STORZ 629825 manufactured by Karl Storz Gmbh & Co. Kg.
[1811487]
Allegedly, the doctor was performing a bilateral sinus surgery when a small metal ball at one end of the device broke off and became stuck in patient. They x-rayed patient and confirmed 1 mm ball was present. They tried magnets to remove it, but were unsuccessful. After minor delay, doctor completed procedure. At the time of the event, the doctor stated that he was not rescheduling to retrieve piece; he said it was equivalent to leaving a hemaclip in patient. He stated he does not believe it poses any risk of injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8900337]
This product was discontinued in 2004. We have no other complaints in our system on this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00038 |
| MDR Report Key | 1912728 |
| Report Source | 05 |
| Date Received | 2010-11-22 |
| Date of Report | 2010-11-22 |
| Date of Event | 2010-10-22 |
| Date Facility Aware | 2010-10-22 |
| Report Date | 2010-11-22 |
| Date Reported to FDA | 2010-11-09 |
| Date Reported to Mfgr | 2010-11-09 |
| Date Added to Maude | 2011-04-11 |
| 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 | MITTLESTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 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 | FRONTAL OSTIUM SEEKER |
| Product Code | FGM |
| Date Received | 2010-11-22 |
| Model Number | 629825 |
| Catalog Number | 629825 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-11-22 |