MAUDE Adverse Event Report: BAUSCH + LOMB GMBH BIPOL.PEN 25G 2PIN TAPER; PROBE, RADIOFREQUENCY LESION

Model Number	E7924
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in netherlands reported during endo coagulation heavy bleeding occurred.The patient had permanent damage after the incident.Additional information was requested with no response at the time of this report.
Additional Manufacturer Narrative
The serial number nor a lot number was provided; therefore, the sterilization and lot history records could not be reviewed.Additional information has been requested with no response.This investigation is ongoing.
Additional Manufacturer Narrative
Additional information: the product was discarded.
Event or Problem Description
Additional information: all the patient information has been kept private.It was noted, this was a human failure not a machine failure to their understanding.
Additional Manufacturer Narrative
Additional information: d1 d2 d4.G4 the complaint sample (b)(4) bipolar eraser was not returned for investigation and discarded by the customer.Photos of the sample were not provided.Therefore, the alleged issue could not be verified and the root cause could not be determined.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: BIPOL.PEN 25G 2PIN TAPER
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BAUSCH + LOMB GMBH; heidelberg NY 69123 ; GM 69123
• Manufacturer (Section G): BAUSCH + LOMB GMBH; im schuhmachergewann 4; heidelberg MO 69123 ; GM 69123
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17637621
• Report Number: 0001920664-2023-70081
• Device Sequence Number: 5429271
• Product Code: GXI
• UDI-Device Identifier: 04058935000530
• UDI-Public: (01)04058935000530
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K882802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: E7924
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/25/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown