MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for SUREFORM 60 STAPLER & BLUE RELOAD 480460/48360B manufactured by Intuitive Surgical.
[179417323]
Intuitive surgical, davinci xi sureform 60 stapler delivered a compromised staple line and the blade was also unable to fully retract. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092964 |
| MDR Report Key | 9706293 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-10 |
| Date Added to Maude | 2020-02-13 |
| 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 | SUREFORM 60 STAPLER & BLUE RELOAD |
| Generic Name | ENDOSCOPE AND ACCESSORIES |
| Product Code | GCP |
| Date Received | 2020-02-12 |
| Model Number | 480460/48360B |
| Catalog Number | 480460/48360B |
| Lot Number | L929191202/L91190930 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL |
| Manufacturer Address | SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |