NA 0250181164Recalls & reported problems
Stryker Corporation · PEEK Monopolar Handle · Class 2
Data updated Oct 18, 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 07613327056716), received between Sep 30, 2021 and Dec 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Arcing” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Arcing1
- Temperature Problem1
Patient problems
- Blister1
- No Clinical Signs, Symptoms or Conditions1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2022Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS PATIENT BURN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn
MAUDE report 15988906 ↗MalfunctionSep 30, 2021Arcing
IT WAS REPORTED THAT PRODUCT ARCED RESULTING IN BLISTERS TO THE PATIENT'S SKIN.
Patient problems: Blister
MAUDE report 12558407 ↗
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- Raptor 00711177US Endoscopy · Endoscopic grasping/cutting instrument, non-powered8 reports
- n.a. 27071TJKarl Storz GmbH & Co. KG · Endoscopic grasping/cutting instrument, non-powered6 reports
- Raptor 00711178US Endoscopy · Endoscopic grasping/cutting instrument, non-powered5 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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