MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-05 for BIPOLAR CUTTING LOOP 26040GP1/6 manufactured by Karl Storz Gmbh & Co. Kg.
[5243012]
Allegedly, during a procedure a piece of the loop on the distal end broke off and fell into the patient; she immediately removed it. Procedure was completed and there was no serious injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12636260]
Evaluation of the instrument confirmed that a piece of the loop has broken off the distal end; we believe the break is possibly due to mechanical damage.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9610617-2014-00064 |
MDR Report Key | 4328638 |
Report Source | 05,06 |
Date Received | 2014-12-05 |
Date of Report | 2014-11-04 |
Date of Event | 2014-11-01 |
Date Added to Maude | 2014-12-17 |
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 | BIPOLAR CUTTING LOOP |
Generic Name | BIPOLAR CUTTING LOOP |
Product Code | HIN |
Date Received | 2014-12-05 |
Model Number | 26040GP1/6 |
Catalog Number | 26040GP1/6 |
Lot Number | 47332 |
Device Availability | Y |
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 | 2014-12-05 |