MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SURGIWAND II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	178094
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
According to the reporter, during a laparoscopic colectomy procedure, approximately an hour after starting to use the device as an electric scalpel, surgeon noted the electrode was unstable.During use, he/she checked the device after removing it from the patient, and the electrode broke off.The procedure was completed with another device.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Correction: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed damage may occur if the instrument is used improperly.The instructions for use for this product states: when using electrocautery, ensure that the outer sleeve is fully retracted to expose the tip of the device, as failure to do so may compromise discharge of energy from the electrode.Replication of the disengaged tip may be due to excessive force/leverage applied to the instrument.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIWAND II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7085824
• Report Number: 2647580-2017-08369
• Device Sequence Number: 13860320
• Product Code: GEI
• UDI-Device Identifier: 20884523000914
• UDI-Public: 20884523000914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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 Expiration Date: 08/31/2022
• Device Model Number: 178094
• Device Catalogue Number: 178094
• Device Lot Number: P7H0105X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1