Scintillant 2658-01-0002Recalls & reported problems
BihlerMed, L.L.C. · Scintillant Surgical Light with Suction · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10865082000129), received between Jun 4, 2018 and Jun 4, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2018Detachment Of Device Component; Detachment Of Device Component
THE LENS FROM THE SURGICAL LIGHT FELL OFF WHILE IN USE ON A PATIENT. THE LENS WAS ABLE TO BE RETRIEVED. THERE WAS NO INJURY, DELAY IN SURGERY, OR ANY ADDITIONAL PROCEDURES REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7566660 ↗
Other Catheter And Tip, Suction devices
- J-VAC 2160Ethicon Inc. · CATHETER AND TIP, SUCTION152 reports
- Wayne G56537Cook Incorporated · CATHETER AND TIP, SUCTION2 recalls33 reports
- Bard® Suction Connector EN0066000C. R. Bard, Inc. · CATHETER AND TIP, SUCTION1 recall6 reports
- CLEARVIEW® 31200Medtronic, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- ARROW IPN039282Teleflex Incorporated · CATHETER AND TIP, SUCTION1 recall0 reports
- ARROW IPN037088Teleflex Incorporated · CATHETER AND TIP, SUCTION1 recall0 reports
- ARROW IPN922898Teleflex Incorporated · CATHETER AND TIP, SUCTION1 recall0 reports
- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page