MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for INNER TUBE WITH CERAMIC BEAK 27050XA manufactured by Karl Storz Gmbh Co. Kg.
[105395479]
Patient Sequence No: 1, Text Type: N, H10
[105395480]
Patient was in the operating room (or) for a cystoscopy and transurethral resection of the prostate (turp). Inner sheath of karl storz instrument had the tip covered in plastic. Plastic cracked and pieces of plastic broke off into the patient bladder. Dr. Irrigated and used graspers to retrieve the pieces of plastic. He irrigated the bladder copiously and inspected the bladder thoroughly under video endoscopy to ensure no pieces were left in the bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428297 |
| MDR Report Key | 7428297 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-10 |
| Report Date | 2018-04-12 |
| Date Reported to FDA | 2018-04-12 |
| Date Reported to Mfgr | 2018-04-12 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNER TUBE WITH CERAMIC BEAK |
| Generic Name | CYSTOURETHROSCOPE |
| Product Code | FBO |
| Date Received | 2018-04-13 |
| Model Number | 27050XA |
| Catalog Number | 27050XA |
| Lot Number | SW06 |
| ID Number | 26 FR INNER CONTINUOUS IRRIGA |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH CO. KG |
| Manufacturer Address | 2151 E GRAND AVE. EL SEGUNDO CA 902455017 US 902455017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |