MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for SUREFORM 480460 manufactured by Intuitive Surgical, Inc..
[185040939]
Stapler would not identify 2 different staple loads. Stapler said staples were already used. Manufacturer response for xi (sk1893), xi/xi dual/x stpler, sureform 60, spu (per site reporter). Intuitive has received the part associated with this complaint and completed investigations. Failure analysis investigations confirmed but not replicated the customer reported complaint ''stapler would not identify 2 different staple loads. " the instrument was found to have 5 reload recognition lock out failures based on log review but was not replicated in house. The instrument initialized, clamped, fired and unclamped without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882475 |
| MDR Report Key | 9882475 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-10-22 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2019-11-14 |
| Model Number | 480460 |
| Catalog Number | 480460 |
| Lot Number | L91190513 |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC. |
| Manufacturer Address | 1266 KIFER RIAD SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |