MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-27 for KARL STORZ 10350H manufactured by Karl Storz Gmbh & Co..
[18928682]
The date and information contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary information received by karl storz, who has not conclusively determined the cause of the adverse event. This mdr is therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any karl storz products were causally related to the incident. Allegedly, during a foreign object removal procedure, the jaw of the optical forceps broke off into the patient's lung. The doctor was able to retrieve the foreign object but not the jaw of the forceps due to its location. The doctor induced coughing to change position of the jaw within patient, but this was unsuccessful and caused patient stress due to asthmatic condition. The doctor felt it was riskier to attempt removal than leave it in at this time. Patient was release and had a follow up visit scheduled.
Patient Sequence No: 1, Text Type: D, B5
[19212980]
Risk management is not releasing instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2014-00010 |
| MDR Report Key | 3786369 |
| Report Source | 05 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-02-06 |
| Device Manufacturer Date | 1991-11-01 |
| Date Added to Maude | 2014-05-27 |
| 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 Contact | SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242198201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 78503 TUTTLINGEN DE |
| Manufacturer City | TUTTLINGEN DE |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | OPTICAL FORCEPS |
| Product Code | BWH |
| Date Received | 2014-03-27 |
| Model Number | 10350H |
| Catalog Number | 10350H |
| Lot Number | LT |
| 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. |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-27 |