COBLATION EICA8872-01 (UDI 00817470009743)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470009743), received between Mar 27, 2020 and Apr 9, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K142999); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2020Detachment of Device or Device Component

  PROCISE XP WAND WAS USED FOR TONSILLECTOMY WHEN USER NOTICED TIP OF WAND MISSING AFTER USE. SMALL PIECE WAS SUCTIONED BY SURGEON, WITH NO HARM TO THE PATIENT AND NO ADDITIONAL FOLLOW UP NEEDED. THE PRODUCT WAS KEPT AND WILL BE RETURNED FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, COBLATION (PER SITE REPORTER). MATERIAL'S MANAGEMENT FOR THE OR NOTIFIED THE MANUFACTURER. AN RA WAS PROVIDED AND THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9943344 ↗
• MalfunctionMar 27, 2020Break; Detachment of Device or Device Component

  COBLATOR WAND WAS USED FOR SURGERY AND PART OF THE SMALL METAL TIP BROKE OFF. DEVICE WAS REMOVED FROM STERILE FIELD AND REPLACED. NO HARM CAME TO THE PATIENT, AND SMALL METAL TIP WAS SUCTIONED AWAY. DEVICE WAS GIVEN TO OPERATING ROOM MATERIAL'S MANAGEMENT STAFF WHO MANAGED A RETURN OF THE DEVICE. IT WAS NOTED THAT A SIMILAR EVENT OCCURRED EARLIER IN THE WEEK. BOTH DEVICES HAVE BEEN ADDED TO THIS REPORT, ALTHOUGH IT IS UNCLEAR WHICH LOT NUMBER CORRESPONDS WITH THIS PATIENT AND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142999. One submission often covers many models, so check the product and lot details in each record.

• Z-2105-2015 · Jun 2, 2015 · Terminated
  EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tiss
• Z-1833-2015 · May 15, 2015 · Terminated
  PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of bl
• Z-1832-2015 · May 15, 2015 · Terminated
  EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood