FDA Adverse Event
Malfunction
Summary report: N
SUREFORM
MDR report key: 23363311
·
Received October 22, 2025
Report
- Report Number
- 2955842-2025-42411
- Event Type
- Malfunction
- Date Received
- October 22, 2025
- Date of Event
- August 13, 2025
- Report Date
- September 29, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GDW
- UDI-DI
- 10886874121723
- PMA / PMN Number
- K211997
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.
Description of Event or Problem · 0
ON 29-SEP-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5175135 STATING: "STAPLER MISFIRED. ERROR MESSAGE STATED, "TOO MUCH TISSUE IN THE STAPLER JAW". STAPLE FOUND LYING ACROSS THE STAPLE FIRING LINE ON THE JAW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228817 | SUREFORM | 8MM STAPLER | GDW | INTUITIVE SURGICAL, INC | 488530-13 | K10250507 | 10886874121723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | DA VINCI INSTRUMENTS AND ACCESSORIES. |