MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E4073-CT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the left tip of the forceps is severely bent.Both tips are burnt and discolored and the tine stop is missing/broken off.The stop was not returned with the device.The reported condition was confirmed.The device was sent to the supplier for evaluation.The supplier found the left tip of the forceps is severely bent.Both tips are burnt and discolored and the tine stop is missing/broken off.The stop was not returned with the device.It appears excessive prying force was applied to the tine tip of the instrument was dropped.The overall condition of the instrument is poor.It appears that this instrument has not been maintained properly per the instructions for use (ifu).Given the condition and age of this instrument, it appears that it may have been used beyond the 25 uses it is validated for.The investigation identified the root cause of the reported event to be user mishandling.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the unit tip part was deformed.There was no patient involvement.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): KIRWAN SURGICAL PRODUCTS; 180 enterprise dr; marshfield MA 02050 2110
• MDR Report Key: 9742230
• Report Number: 1717344-2020-00173
• Device Sequence Number: 1802332
• Product Code: GEI
• UDI-Device Identifier: 10884524000848
• UDI-Public: 10884524000848
• 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,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: E4073-CT
• Device Catalogue Number: E4073-CT
• Device Lot Number: M4779707X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1