MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADAPTER FOR WOLF HYSTEROSCOPE; HYSTEROSCOPE ACCESSORIES

Model Number 55034

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Patient presented to the operating room (or) for a planned dilation and curettage (d&c), hydrothermal ablation (hta) procedure.During the surgery, the hta equipment failed, allowing the scope to become incredibly hot and burned this patient's vaginal opening and cervix.We learned that the wolf hysteroscope adapter was supposed to be replaced at every 40 uses which we did not do.We have discarded all of our supply from 2005 and have ordered all new.

Event Description

Patient presented to the operating room (or) for a planned dilation and curettage (d&c), hydrothermal ablation (hta) procedure.During the surgery, the hta equipment failed, allowing the scope to become incredibly hot and burned this patient's vaginal opening and cervix.We learned that the wolf hysteroscope adapter was supposed to be replaced at every 40 uses which we did not do.We have discarded all of our supply from 2005 and have ordered all new.

Event Description

Patient presented to the operating room (or) for a planned dilation and curettage (d&c), hydrothermal ablation (hta) procedure.During the surgery, the hta equipment failed, allowing the scope to become incredibly hot and burned this patient's vaginal opening and cervix.We learned that the wolf hysteroscope adapter was supposed to be replaced at every 40 uses which we did not do.We have discarded all of our supply from 2005 and have ordered all new.

• Brand Name: ADAPTER FOR WOLF HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 18747288
• MDR Text Key: 335870961
• Report Number: 18747288
• Device Sequence Number: 1
• Product Code: NWW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55034
• Device Catalogue Number: 55034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2024
• Device Age: 19 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 67 KG