SHARK/S-LINE 46300243Recalls & reported problems
Richard Wolf GmbH · BIVAP ELECTRODE BIPO 24-26FR 12/30° for Shark resectoscopes, telescope Ø 4 mm, suitable for sheaths from 24 Fr, electrode shape: torus, PACK = 3 pcs., sterile, in individual packaging, for single use · Class 2
All models of SHARK/S-LINE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207048948), received between Jan 10, 2019 and Nov 20, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation3
- Adverse Event Without Identified Device or Use Problem1
- Melted1
- Thermal Decomposition of Device1
Patient problems
- Insufficient Information2
- Burn, Thermal1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT "THE RESECTION LOOP BROKE DURING THE OPERATION. A PIECE APPEARS TO HAVE REMAINED IN THE PATIENT'S UTERUS."
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20738104 ↗MalfunctionMay 6, 2021Thermal Decomposition of Device; Material Fragmentation; Melted; Thermal Decomposition of Device; Material Fragmentation; Melted
RW RECEIVED A RESPONSE FROM THE USER FACILITY TO MEDWATCH QUESTIONNAIRE, THIS REPORT IS TO THE SHARE THOSE DETAILS (PATIENT DETAILS ABOUT THE FIRST PROCEDURE) WITH THE FDA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11787536 ↗MalfunctionJan 11, 2021Material Fragmentation; Material Fragmentation
THIS FOLLOW UP REPORT IS TO PROVIDE THE COMPLAINT INVESTIGATION. THE FULL DESCRIPTION OF THE FINDINGS IS PROVIDED IN THE SECTION H10 OFTHIS REPORT.
Patient problems: Insufficient Information
MAUDE report 11149120 ↗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 1418479-2018-00053), 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30 (MDR).
Patient problems: Burn, Thermal
MAUDE report 8238012 ↗
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- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
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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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