MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-16 for 27760272U1-SH 27750300U1 manufactured by Karl Storz Endoscopy-america, Inc..
[60010598]
Patient Sequence No: 1, Text Type: N, H10
[60010599]
During the procedure the laser fiber broke off inside the patient. The broken piece was removed from the patient's bladder, however, the surgical staff were not able to secure the broken piece of laser fiber when it was removed and it was lost in the patient's drapes. The piece was very tiny, clear, and transparent. The piece not able to be detected by xray. The main piece of the laser fiber was secured into a collection bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6105533 |
| MDR Report Key | 6105533 |
| Date Received | 2016-11-16 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-10-10 |
| Report Date | 2016-10-12 |
| Date Reported to FDA | 2016-10-12 |
| Date Reported to Mfgr | 2016-10-12 |
| Date Added to Maude | 2016-11-16 |
| 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 |
| Generic Name | FIBER, LASER, SHEATH |
| Product Code | MVG |
| Date Received | 2016-11-16 |
| Model Number | 27760272U1-SH |
| Catalog Number | 27750300U1 |
| Lot Number | M11546 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-16 |