MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-17 for BIPOLAR CUTTING LOOP 26040GP1 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[83112843]
Evaluation of the instrument confirmed that part of the wire loop has broken off the distal end. The esu was being run at maximum settings. We believe cause of breakage was too high an esu setting.
Patient Sequence No: 1, Text Type: N, H10
[83112846]
Allegedly, during a hysteroscopic resection of polyp which turned into resection of fibroid procedure the doctor noted that the loop broke and a piece fell into the patient. The doctor immediately removed the broken piece and replaced the electrode and went on to complete the case. The hospital reported there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00066 |
| MDR Report Key | 6802521 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-13 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-08-17 |
| 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 | 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 |
| Manufacturer Street | MITTLESTRASSE 8 78503 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR CUTTING LOOP |
| Generic Name | SCISSORS INSERT |
| Product Code | HIN |
| Date Received | 2017-08-17 |
| Returned To Mfg | 2017-08-03 |
| Model Number | 26040GP1 |
| Catalog Number | 26040GP1 |
| Lot Number | UT07 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-17 |