S-LINE 8680224Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04055207042946), received between Jun 28, 2017 and Jun 8, 2021 — classified as 3 injuries, 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Unintended Electrical Shock; Unintended Electrical Shock

  THE PURPOSE OF THIS REPORT IS TO REPORT THE DEVICE EVALUATION/INVESTIGATION RESULTS. PLEASE SEE MANUFACTURERS NARRATIVE.

  Patient problems: Electric Shock

  MAUDE report 11957808 ↗
• 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 LAWSUIT 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), 46300223 BIVAP ELECTRODE BIPO 22FR 12/30 (MDR 1418479-2018-00053), 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30 (1418479-2018-00054).

  Patient problems: Burn, Thermal

  MAUDE report 8237997 ↗
• InjuryAug 22, 2017Bent

  FOLLOW UP REPORT #1. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED ADDITIONAL INFORMATION FROM FACILITY ON 20SEP2017. THE FOLLOWING BOXES HAVE BEEN UPDATED/COMPLETED: PATIENT INFORMATION. DATE DESCRIPTION. SUSPECT DEVICE -(NOT CHANGED, ON MISSING DATA REPORT). INITIATOR ADDRESS. IMPORTER INFORMATION.

  Patient problems: Shock

  MAUDE report 6810262 ↗
• InjuryAug 22, 2017Bent

  (B)(4) SALES REPRESENTATIVES WAS NOTIFIED BY FACILITY THAT DURING A BIPOLAR TURBT PROCEDURE TWO NURSES WERE SHOCKED WHEN THEY GRABBED THE BIZ MONITOR DEVICE WHILE REMOVING IT FROM THE PATIENT. NO INJURY TO PATIENT WAS REPORTED. TWO SEPARATE MDRS WILL BE SUBMITTED, ONE FOR EACH NURSE: MDR 1418479-2017-00018, NURSE #1, MDR 1418479-2017-00019, NURSE #2. USER FACILITY WAS CONTACTED IN AN EFFORT TO GATHER ADDITIONAL/MISSING MEDWATCH INFORMATION, NO RESPONSE AS OF 08/22/17. MANUFACTURER / DEVICE RETURNED FOR INVESTIGATION: (B)(4) WORKING ELEMENT (ID #8680.224 LT #1324186), (B)(4) ELECTRODE (ID #4622.1313 LT #51007450), (B)(4) BIPOLAR CABLE (ID #8108.232 LT #07/14), (B)(4) UNIPOLAR CABLE (ID #815.033 LOT #128/180). ADDITIONAL DEVICES USED DURING PROCEDURE: (B)(4) GENERATOR (ID #UNKNOWN), BIZ MONITOR (ID #UNKNOWN). MANUFACTURED DATE: 12-OCT-2016, PURCHASE DATE: (B)(6) 2017, SERVICE DATE: N/A. (B)(4) RECEIVED ACTUAL DEVICE FROM USER FACILITY ON 03-AUG-2017. A VISUAL INSPECTION OF DEVICE FOUND SHAFT WAS BENT. NO PROBLEMS FOUND WHEN FUNCTIONAL TESTING WAS PERFORMED ON DEVICE. (B)(4) COULD NOT REPLICATE EVENT WITH THE DEVICES RETURNED FOR INVESTIGATION. NONE OF THE RETURNED DEVICES CONTAINED D

  Patient problems: Shock

  MAUDE report 6810257 ↗
• MalfunctionJun 28, 2017Unintended Power Up; Grounding Malfunction; Unintended Power Up; Grounding Malfunction

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY USER FACILITY THAT DURING A PROCEDURE THE ANESTHESIOLOGIST TOUCHED AN EKG ELECTRODE AND WAS BURNED ON THE FINGER. NO INJURY TO THE PATIENT WAS REPORTED. OCCURED APPROXIMATELY TWO YEARS AGO. THIS EVENT HAS OCCURRED ON THREE SEPARATE OCCASIONS: 1) (B)(6) 2017 - MDR 1418479-2017-00014. 2) (B)(6) 2017 - MDR 1418479-2017-00015. 3) (B)(6) 2015 - MDR 1418479-2017-00016. USER FACILITY CONTACTED IN AN EFFORT TO GATHER ADDITIONAL/MISSING INFORMATION, NO RESPONSE AS OF 06/28/17. LIST OF RWMIC ITEMS USED DURING PROCEDURE: 1) WORKING ELEMENT (ID #8680.224), 2) ELECTRODE (ID #4622.1333). . LIST OF RWMIC (B)(6) ITEMS USED DURING PROCEDURE: 1) INNER SHEATH (ID #8655.3841), 2) OUTER SHEATH (ID #8655.374), 3) CONNECTOR (ID #8654.3742). LIST OF OTHER KNOWN ITEMS USED DURING PROCEDURE: 1) ERBE VIO GENERATOR (ID #UNKNOWN), 2) ERBE BIPOLAR CABLE (ID #8108.232), 3) EKG MONITOR (ID #UNKNOWN). SUSPECT DEVICE AT THIS TIME IS THE WORKING ELEMENT ID #8680.224.

  Patient problems: Lead(s), Burn(s) From; No Consequences Or Impact To Patient

  MAUDE report 6675287 ↗
• MalfunctionJun 28, 2017Unintended Power Up; Grounding Malfunction; Unintended Power Up; Grounding Malfunction

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY USER FACILITY THAT DURING A PROCEDURE THE ANESTHESIOLOGIST TOUCHED AN EKG ELECTRODE AND WAS BURNED ON THE FINGER. NO INJURY TO THE PATIENT WAS REPORTED. THIS EVENT HAS OCCURRED ON THREE SEPARATE OCCASIONS: ON (B)(6) 2017 - MDR 1418479-2017-00014, ON (B)(6) 2017 - MDR 1418479-2017-00015, ON (B)(6) 2015 - MDR 1418479-2017-00016. USER FACILITY CONTACTED IN AN EFFORT TO GATHER ADDITIONAL/MISSING INFORMATION, NO RESPONSE AS OF 06/23/17. LIST OF RWMIC ITEMS USED DURING PROCEDURE: WORKING ELEMENT (ID #8680.224), ELECTRODE (ID #4622.1333). LIST OF RWMIC (B)(4) ITEMS USED DURING PROCEDURE: INNER SHEATH (ID #8655.3841), OUTER SHEATH (ID #8655.374), CONNECTOR (ID #8654.3742). LIST OF OTHER KNOWN ITEMS USED DURING PROCEDURE: ERBE VIO GENERATOR (ID #UNKNOWN), ERBE BIPOLAR CABLE (ID #8108.232), EKG MONITOR (ID #UNKNOWN). SUSPECT DEVICE AT THIS TIME IS THE WORKING ELEMENT ID #8680.224.

  Patient problems: Lead(s), Burn(s) From; No Consequences Or Impact To Patient

  MAUDE report 6675285 ↗
• MalfunctionJun 28, 2017Unintended Power Up; Grounding Malfunction; Unintended Power Up; Grounding Malfunction

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY USER FACILITY THAT DURING A PROCEDURE THE ANESTHESIOLOGIST TOUCHED AN EKG ELECTRODE AND WAS BURNED ON THE FINGER. NO INJURY TO THE PATIENT WAS REPORTED. THIS EVENT HAS OCCURRED ON THREE SEPARATE OCCASIONS: (B)(6). USER FACILITY CONTACTED IN AN EFFORT TO GATHER ADDITIONAL/MISSING INFORMATION, NO RESPONSE AS OF 06/23/2017. LIST OF RWMIC ITEMS USED DURING PROCEDURE: WORKING ELEMENT (ID #8680.224). ELECTRODE (ID #4622.1333). LIST OF RWMIC (B)(4) ITEMS USED DURING PROCEDURE: INNER SHEATH (ID #8655.3841). OUTER SHEATH (ID #8655.374). CONNECTOR (ID #8654.3742). LIST OF OTHER KNOWN ITEMS USED DURING PROCEDURE: ERBE VIO GENERATOR (ID #UNKNOWN). ERBE BIPOLAR CABLE (ID #8108.232). EKG MONITOR (ID #UNKNOWN). SUSPECT DEVICE AT THIS TIME IS THE WORKING ELEMENT ID #8680.224.

  Patient problems: Lead(s), Burn(s) From; No Consequences Or Impact To Patient

  MAUDE report 6675277 ↗