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SHARK/S-LINE 46300223Recalls & reported problems

Richard Wolf GmbH · BIVAP ELECTRODE BIPO 22FR 12/30° for Shark resectoscopes, telescope Ø 4 mm, suitable for sheaths from 22 Fr, electrode shape: torus, PACK = 3 pcs., sterile, in individual packaging, for single use · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207048931), received between Jan 10, 2019 and May 6, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Fragmentation1
  • Melted1
  • Thermal Decomposition of Device1

Patient problems

  • Burn, Thermal1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 6, 2021Thermal Decomposition of Device; Material Fragmentation; Melted; Thermal Decomposition of Device; Material Fragmentation; Melted

    IT WAS REPORTED BY THE USER FACILITY TO RICHARD WOLF THAT "AFTER 40 MINUTES OF USE, THE INSULATION MELTED, ONE OF THE PRONGS BROKE, AND THE INSTRUMENT BECAME ENCRUSTED WITH A BLACK CHARRED MATERIAL." THE ITEM WAS DISCARDED AT THE FACILITY. ADDITIONALLY: WILL THE DEVICE BE RETURNED? NO. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? NO. DID THE DELAY PUT THE PATIENT AT RISK? N/A. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11787704 ↗
  • InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS SERVED WITH A PATIENT LAW SUIT INVOLVING A "BUTTON TYPE BIPOLAR PROSTATE RESECTOR AND/OR ELECTROSURGICAL GENERATOR". ON (B)(6) 2016, THE PATIENT UNDERWENT A PROCEDURE DESCRIBED AS "CYSTOSCOPY WITH URETHRAL DILATION, TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH BIPOLAR". DURING SAID PROCEDURE, THE PATIENT WAS UNDER GENERAL ANESTHESIA AND SUFFERED THERMAL INJURY TO THEIR BLADDER AND URETHRA. AT THIS TIME, THE INVOLVEMENT OF RICHARD WOLF PRODUCTS HAS NOT BEEN CONFIRMED. HOWEVER, THE FOLLOWING ARE CONSIDERED SUSPECT PRODUCTS AND MDRS WILL BE SUBMITTED FOR EACH UNTIL THE USER FACILITY IS ABLE TO CONFIRM THAT NO RICHARD WOLF PRODUCTS WERE INVOLVED: 8680.225 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR 1418479-2018-00051), 8680.224 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR 1418479-2018-00052), 46300223 BIVAP ELECTRODE BIPO 22FR 12/30 (MDR), 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30 (1418479-2018-00054).

    Patient problems: Burn, Thermal

    MAUDE report 8237969 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.