MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for KARL STORZ OBTURATOR SHEATH manufactured by Karl Storz Endoscopy-america, Inc..
[184665423]
On (b)(6) 2019 pt had a transurethral resection of bladder greater than 3 cm. During the week of (b)(6) pt had an in-office scope where physician noticed small particles in bladder. This was believed to be parts of the plastic end of an obturator sheath. On (b)(6) 2020 physician performed a cystoscopy with fulguration and biopsy of bladder tumor and removal of foreign body. Pieces were retrieved. Sheath from central sterile had been found with broken end and removed from service. Rep of company notified. Physician said pt had experienced no issues due to the foreign body and would have had the procedure regardless. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093865 |
| MDR Report Key | 9865104 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-18 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | KARL STORZ OBTURATOR SHEATH |
| Generic Name | CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID |
| Product Code | FAJ |
| Date Received | 2020-03-20 |
| Lot Number | 0123 LOT CI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |