MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for BALLOON CATHETER 11583BP manufactured by Karl Storz Se & Co. Kg.
[104545554]
The balloon catheter will not be returned to karl storz for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[104545555]
Allegedly, during a sialendoscopy, the tip of the balloon catheter broke off inside the patient's gland. The physician indicated that all of the broken pieces were retrieved. The doctor used another instrument and completed the procedure with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00025 |
| MDR Report Key | 7398266 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-03-14 |
| Date Added to Maude | 2018-04-04 |
| 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 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BALLOON CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | GBA |
| Date Received | 2018-04-04 |
| Model Number | 11583BP |
| Catalog Number | 11583BP |
| Lot Number | 8331010 |
| 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 | 1. Required No Informationntervention | 2018-04-04 |