MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480460

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Staple load failure with resulting leak requiring two subsequent surgical interventions.Surgeon was proceeding with robotic revision roux-en-y and fired a blue 60mm staple load using the sureform 60 endoscopic motorized cutting stapler.Upon stapler completion, it was noted that staple load had cut tissue but not stapled on either side of cut causing gastric contents to leak out.A subsequent 60mm blue load was used to complete the intended cut.After this was done, surgeon noted pancreatic tissue near area of subsequent cut/staple.Doctor then verbalized concern that pancreatic injury may have occurred.Another surgeon was consulted and came to verify that no pancreatic injury had indeed occurred.Retroperitoneal tissue was sent to pathology to verify.Repair of gastroesophageal junction due to failed stapler load was completed.

• Brand Name: SUREFORM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 14186328
• MDR Text Key: 289875252
• Report Number: 14186328
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115640
• UDI-Public: (01)00886874115640
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460
• Device Lot Number: T90211201
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Date Report to Manufacturer: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 124 KG