MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-05-11 for INNER TUBE WITH CERAMIC BEAK 27050XA manufactured by Karl Storz Se & Co. Kg.
[108162712]
We evaluated the returned device and found the entire ceramic beak is missing from the distal end of inner tube and the shaft is dented. Damage is most likely due to the ceramic beak making contact with a hard surface causing an internal crack and resulting in breakage; we cannot confirm.
Patient Sequence No: 1, Text Type: N, H10
[108162713]
Allegedly, during a turp procedure, the tip of inner tube cracked and pieces broke off into the patient bladder. Doctor irrigated and used graspers to retrieve the pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00035 |
| MDR Report Key | 7509145 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2018-05-11 |
| 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 SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER TUBE WITH CERAMIC BEAK |
| Generic Name | RESECTOSCOPE SHEATH INNER TUBE |
| Product Code | FBO |
| Date Received | 2018-05-11 |
| Returned To Mfg | 2018-05-04 |
| Model Number | 27050XA |
| Catalog Number | 27050XA |
| Lot Number | SW06 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 5 YR |
| 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 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-11 |