YelloPort Plus - Laparoscopic Port Access SystemRecalls & reported problems across all models
Surgical Innovations Limited · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one YelloPort Plus - Laparoscopic Port Access System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 7 models of YelloPort Plus - Laparoscopic Port Access System by Surgical Innovations Limited in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2017 and Jul 30, 2026 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
YelloPort Plus - Laparoscopic Port Access System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 20, 2022Open, Classified
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Z-1853-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported YelloPort Plus - Laparoscopic Port Access System problems
Device problems
- Break6
- Component Missing2
- Detachment Of Device Component2
- Device Markings/Labelling Problem2
- Crack1
- Device Or Device Fragments Location Unknown1
- Gas/Air Leak1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
YelloPort Plus - Laparoscopic Port Access System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- YelloPort Plus - Laparoscopic Port Access System YC0507001Laparoscope, General & Plastic Surgery1 recall1 report
- YelloPort Plus - Laparoscopic Port Access System YA05VSS01Laparoscope, General & Plastic Surgery4 reports
- YelloPort Plus - Laparoscopic Port Access System YA512STSALaparoscope, General & Plastic Surgery3 reports
- YelloPort Plus - Laparoscopic Port Access System YC0515010Laparoscope, General & Plastic Surgery2 reports
- YelloPort Plus - Laparoscopic Port Access System YC0507011Laparoscope, General & Plastic Surgery1 report
- YelloPort Plus - Laparoscopic Port Access System YC0509501Laparoscope, General & Plastic Surgery1 report
- YelloPort Plus - Laparoscopic Port Access System YC1210522Laparoscope, General & Plastic Surgery1 report
Recent YelloPort Plus - Laparoscopic Port Access System adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Material Fragmentation
Description: During the closure phase of the TAPP procedure, a missing valve was noticed; a search for the missing part was conducted but it was not found within the abdominal cavity, and the abdomen was closed.The patient is to be kept under observation. The valve has been discarded.Combined equipment: Forceps by STORZ.Confirmed: The valve was damaged during the surgery, and a part of the valve was missing. Also, the damaged valve was discarded in the hospital.Conclusion after investigation: Based on previous complaint investigations, this failure mode has only been observed where instrument tips were slightly open during insertion and subsequently pushed through the valve, resulting in a tear. Given the consistency of this failure mechanism with previous investigations, the root cause is concluded to be user error during instrument insertion. Given the frequency of reported events over the previous 12 months, a CAPA will be raised to further investigate this issue and implement appropriate measures to prevent future occurrences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082146 ↗MalfunctionJan 17, 2022Device Markings/Labelling Problem
AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.
Patient problems: Insufficient Information
MAUDE report 13265034 ↗MalfunctionOct 21, 2020Material Separation
BEFORE THE LAP PROCEDURE, NURSE OPENED THE PACKAGE AS USUAL AND CHECKED THE VALVE BRIEFLY. HOWEVER, AFTER THE PROCEDURE COMPLETED, THE NURSE DISSEMBLED THE REUSABLE AND DISPOSABLE PARTS OF TROCAR, SHE FOUND THERE WAS MISSING PORTION ON THAT VALVE AND THEY COULDN'T FIND IT ANYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10710626 ↗MalfunctionOct 1, 2020Material Split, Cut or Torn
DAMAGE AND TEARING OF THE 12MM AND 10MM SEALS ON SWINGTOP. FROM PHOTOGRAPH OF THE DEVICE, PARTS OF THE BLUE 10MM AND RED 12MM SEALS ARE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10612047 ↗InjuryMar 9, 2020Break; Component Missing
THE CONCERNED PRODUCT WAS USED DURING PROCEDURE OF ABDOMINAL WALL SCAR HERNIA ON NOVEMBER 6TH, WEDNESDAY, WITHOUT ANY ISSUE. HOWEVER, THEY REALIZED THAT DISTAL END OF THE CANNULA WAS BROKEN AND MISSING WHEN THEY VISUALLY INSPECTED THE PRODUCT AFTER STERILIZATION. THEY WATCHED RECORDED VIDEO IN ORDER TO FIND THE MISSING PART AND CONFIRMED IT WAS DROPPED INSIDE THE PATIENT DURING PROCEDURE. TO RETRIEVE THE MISSING PART, SECOND LAPAROSCOPIC OPERATION WAS MADE. SINCE THE MISSING PART WAS DIFFICULT TO FIND, THEY SWITCHED THE OPERATION TO OPEN SURGERY AND MADE 10CM SURGICAL INCISION WAS MADE IN THE WALL OF THE ABDOMEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9806060 ↗MalfunctionNov 5, 2019Break; Melted
DURING SURGERY, A PROBE WAS INSERTED, AND PULLED OUT THROUGH YA05VSS01 SILICONE VALVE, AND OUR CUSTOMER FOUND THE PRODUCT WAS MELTED, AND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9279092 ↗MalfunctionJul 23, 2018Break; Gas/Air Leak
DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS. DURING A PROCEDURE, THE DOCTOR CONFIRMED AIR LEAKAGE AND THE VALVE WAS DAMAGED. IT HAPPENED 5MINS AFTER THE BEGINNING OF SURGERY. HE/ SHE USED A GRASPING FORCEPS AND INSERTED JUST ONCE. THE USER COULD NOT FIND THE BROKEN PARTS.
Patient problems: No Information
MAUDE report 7709657 ↗MalfunctionNov 27, 2017Break; Detachment Of Device Component
A DISTRIBUTOR REPORTED A COMPLAINT TO SURGICAL INNOVATIONS. THE COMPLAINT DETAILS STATE, DURING A LAPAROSCOPIC APPENDECTOMY SURGERY, A DOCTOR FOUND A BREAK ON TOP OF THE CANNULA (2 DEVICES AFFECTED) AFTER 30 MINUTES OF THE SURGERY. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. A X-RAY AND CT SCAN WERE CARRIED OUT TO LOCATE THE MISSING PIECE HOWEVER NO PIECE WAS FOUND. THE DISTRIBUTOR HAS CONFIRMED THAT THERE WAS NO PATIENT HARM OR DEATH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7058925 ↗MalfunctionNov 27, 2017Device Markings/Labelling Problem
A DISTRIBUTOR REPORTED THAT THEY RECIEVED SOME DEVICES LABELLED (PRIMARY PACKAGING) AS NON-STERILE AND THE SECONDARY PACKAGING WAS LABELLED AS STERILE. THE DEVICE SUPPLIED TO THE DISTRIBUTOR IS A STERILE DEVICE. THE ISSUE WAS DISCOVERED DURING STOCK INVENTORY. THE DISTRIBUTOR HAS CONFIRMED, TO THE BEST OF THEIR KNOWLEDGE NO PRODUCT LABELLED AS NON-STERILE WAS USED IN A CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7058460 ↗MalfunctionNov 27, 2017Crack
A DISTRIBUTOR REPORTED A COMPLAINT THAT AN END USER NOTICED A CRACK ON THE TIP OF A CANNULA. THE DISTRIBUTOR STATED THAT A PIECE MAY HAVE BEEN DROPPED INSIDE OF THE PATIENT, AN XRAY WAS CARRIED OUT BUT THE PIECE COULD NOT BE FOUND. THE END USER HAS CONFIRMED THAT THE DEVICE WAS CHECKED PRIOR TO STERILISATION AND THERE WAS NO DAMAGE PRESENT, DEVICES ARE NOT CHECKED PRIOR TO USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7058441 ↗MalfunctionNov 27, 2017Component Missing; Device Or Device Fragments Location Unknown
A DISTRIBUTOR REPORTED THAT A CUSTOMER NOTICED A PIECE MISSING ON A SWINGTOP DEVICE AFTER 3 HOURS OF OPERATION. THE DOCTOR USED A 10MM STORTZ CAMERA SCOPE INSTRUMENT WITH THE DEVICE. AN XRAY WAS CARRIED OUT TO LOCATE THE MISSING PIECE INSIDE THE PATIENT, THE PIECE WAS NOT FOUND.
Patient problems: No Code Available
MAUDE report 7058435 ↗MalfunctionNov 24, 2017Break
A DISTRIBUTOR REPORTED THAT A YELLOPORT PLUS CANNULA BROKE INSIDE A PATIENT DURING AN OPERATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7057401 ↗MalfunctionNov 16, 2017Break; Detachment Of Device Component
A DISTRIBUTOR REPORTED AN INCIDENT THAT OCCURED AT A HOSPITAL ((B)(6)). DURING SURGERY, A SMALL PART FROM THE TIP OF A YELLOPORT CANNULA BROKE OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7036505 ↗
Other Surgical Innovations Limited products
All Surgical Innovations Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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