MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for INNER TUBE WITH CERAMIC BEAK 27050XA manufactured by Karl Storz Se & Co. Kg.
[112289291]
The subject device has not yet been returned for evaluation. The device is approximately 3 years old; the most likely cause of this type of breakage is mechanical force.
Patient Sequence No: 1, Text Type: N, H10
[112289292]
Allegedly, during an intra-uterine fibroid resection procedure, the tip of inner tube cracked and pieces broke off into the patient. Doctor was able to retrieve the pieces and confirmed there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00042 |
| MDR Report Key | 7631898 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2018-06-22 |
| 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 | 0 |
| Brand Name | INNER TUBE WITH CERAMIC BEAK |
| Generic Name | RESECTOSCOPE SHEATH INNER TUBE |
| Product Code | FBO |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-07-02 |
| Model Number | 27050XA |
| Catalog Number | 27050XA |
| Lot Number | TU10 |
| 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 | 2018-06-22 |