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 2018-03-07 for INNER TUBE WITH CERAMIC BEAK 27050XA manufactured by Karl Storz Se & Co. Kg.
[101978513]
The sheath has not yet returned to karl storz for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[101978514]
Allegedly, during a turp procedure, the ceramic tip of resectoscope sheath broke off inside the patient's bladder. The doctor retrieved the broken piece and completed the procedure. The physician is confident that he removed all the fragments from the patient. Patient is in stable condition and doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00021 |
| MDR Report Key | 7322439 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-07 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2018-03-07 |
| 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 | 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 SE & CO. KG |
| Manufacturer Street | DR.-KARL STORZ-STRASSE 34 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER TUBE WITH CERAMIC BEAK |
| Generic Name | INNER TUBE WITH CERAMIC BEAK |
| Product Code | FBO |
| Date Received | 2018-03-07 |
| Returned To Mfg | 2018-04-05 |
| Model Number | 27050XA |
| Catalog Number | 27050XA |
| Lot Number | NT |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL STORZ-STRASSE 34 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |