MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-09 for KARL STORZ 10378HF manufactured by Karl Storz Gmbh & Co..
[4434129]
Allegedly, during a foreign object removal procedure, the jaw broke off in patient during retrieval. There were 2 objects to retrieve; the doctor used another grasper and removed one of them, but the other object and the jaw of the forceps could not be visualized in esophagus. Fluoroscopy located them in patient's stomach. The doctor took no further actions; he decided it was best to allow patient to pass in the feces at a later time. We received a copy of mdr 4300160000-2013-8019 filed by the hospital from the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2014-00002 |
| MDR Report Key | 3772859 |
| Report Source | 06 |
| Date Received | 2014-01-09 |
| Date of Report | 2013-12-09 |
| Date of Event | 2013-10-06 |
| Date Added to Maude | 2014-05-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2151 E. GRAND AVENUE UNIT #3010202439 |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | OPTICAL ALLIGATOR FORCEPS |
| Product Code | BWH |
| Date Received | 2014-01-09 |
| Model Number | 10378HF |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-09 |