MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-15 for TROCAR 26031G manufactured by Karl Storz Gmbh & Co. Kg.
[5944430]
Allegedly, during a hip diagnostic arthroscopy procedure, the trocar shaft broke in half and a piece fell into the patient. The doctor immediately removed it; and the procedure was completed with no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[13465100]
The instrument has not been returned for evaluation. We are following up with the customer to have the instrument returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2015-00039 |
| MDR Report Key | 4853596 |
| Report Source | 06 |
| Date Received | 2015-06-15 |
| Date of Report | 2015-05-12 |
| Date of Event | 2014-11-28 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Manufacturer Contact | SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVE. |
| 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 |
| 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 | TROCAR |
| Generic Name | TROCAR |
| Product Code | HIN |
| Date Received | 2015-06-15 |
| Model Number | 26031G |
| Catalog Number | 26031G |
| 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. Required No Informationntervention | 2015-06-15 |