MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS SCOVILL/GREENWALD BIPOLA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E4051
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during sterilization prior to procedure, some parts of the device was coming off.There was no patient involved.

• Brand Name: SCOVILL/GREENWALD BIPOLA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS; 180 enterprise drive; marshfield MA 02050 2110
• MDR Report Key: 8918775
• Report Number: 1717344-2019-01077
• Device Sequence Number: 16597201
• Product Code: GEI
• UDI-Device Identifier: 10884524000749
• UDI-Public: 10884524000749
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E4051
• Device Catalogue Number: E4051
• Device Lot Number: M4723201X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1