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 2018-03-01 for INNER SHEATH 27050CA manufactured by Karl Storz Se & Co. Kg.
[101479370]
The inner sheath was not returned to karl storz for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[101479371]
Allegedly, during a photoselective vaporization of prostate (pvp) procedure, a piece of the ceramic beak on resectoscope inner sheath broke off inside the patient's bladder and was retrieved. Doctor performed bladder irrigation post-op and nothing was found; x-ray in the post-anethesia care unit was negative. The hospital reported that there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00019 |
| MDR Report Key | 7308576 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2018-03-01 |
| 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 SHEATH |
| Generic Name | INNER SHEATH |
| Product Code | FBO |
| Date Received | 2018-03-01 |
| Model Number | 27050CA |
| Catalog Number | 27050CA |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-01 |