J-PLASMA® PRECISE™ BVX-330BRRecalls & reported problems
Aspen Surgical Products, Inc. · J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH BLADE, 33cm · Class 2
All models of J-PLASMA PRECISE (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151010720), received between Jun 8, 2018 and Jun 8, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).
5 other recalls cover devices cleared under the same FDA submission (K152570); they may or may not involve this specific model.
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 Component2
- Human Factors Issue2
- Use of Device Problem2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2018Detachment Of Device Component; Use of Device Problem; Human Factors Issue; Detachment Of Device Component; Use of Device Problem; Human Factors Issue
REPORTED COMPLAINT ALLEGED THAT THE PEEK TIP OF THE HANDPIECE FELL OFF DURING A LAPAROSCOPIC ROBOTIC PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7583668 ↗MalfunctionJun 8, 2018Detachment Of Device Component; Use of Device Problem; Human Factors Issue; Detachment Of Device Component; Use of Device Problem; Human Factors Issue
REPORTED COMPLAINT ALLEGED THAT THE PEEK TIP OF THE HANDPIECE FELL OFF DURING A LAPAROSCOPIC ROBOTIC PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7583654 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152570. One submission often covers many models, so check the product and lot details in each record.
- Z-0198-2019 · Jun 18, 2018 · TerminatedJ-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of sof
- Z-2646-2016 · Jul 18, 2016 · TerminatedBVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and lap
- Z-2648-2016 · Jul 18, 2016 · TerminatedBVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and lapa
- Z-2649-2016 · Jul 18, 2016 · TerminatedBVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and la
- Z-2647-2016 · Jul 18, 2016 · TerminatedBVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and la
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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 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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