MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-03-16 for BIPOLAR CUTTING LOOP 26040JB1 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[40530627]
Was scrapped.
Patient Sequence No: 1, Text Type: N, H10
[40530628]
Allegedly, the doctor was performing a laparoscopic procedure when he noted that the cutting loop on the electrode broke off the instrument and fell into the patient. The doctor immediately irrigated to flush the piece out and an x-ray was taken to confirm that there was nothing left inside of the patient. The instrument was replaced and the procedure completed with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00014 |
| MDR Report Key | 5505640 |
| Report Source | USER FACILITY |
| Date Received | 2016-03-16 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-16 |
| 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 Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| 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 | 2016-03-16 |
| Model Number | 26040JB1 |
| Catalog Number | 26040JB1 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-16 |