MAUDE Adverse Event Report: I.C. MEDICAL, INC. EXTENDEVAC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-000702
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 48260) was received for a cautery pencil (finished good 88-000702, lot 49982316) with a button sticking in the "on" position.The end user reported this posed a fire hazard and that remaining product was pulled from the facility's inventory.A sample was not returned for evaluation.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
During use, the cautery button is sticking in the "on" position.
Event or Problem Description
During use, the cautery button is sticking in the "on" position.
Additional Manufacturer Narrative
Root cause: the pencil is supplied to deroyal by i.C.Medical.Therefore, a supplier corrective action request (scar) was issued to i.C.Medical as well as samples for evaluation.Three representative samples were provided for evaluation.In its scar response, i.C.Medical stated testing of the samples could not duplicate the reported failure.No auto activation, continuous activation, or any other unintended activation was observed during testing.The samples functioned normally and within specifications.Corrective action: due to the root cause investigation, no corrective actions are being implemented at this time.Investigation summary: an internal complaint (b)(4)) was received for a cautery pencil (finished good 88-000702, lot 49982316) with a button sticking in the "on" position.The end user reported this posed a fire hazard and that remaining product was pulled from the facility's inventory.Originally, a sample was reported not to be available.However, the customer returned unused samples from the same lot.These were sent to the manufacturer for evaluation.The pencil is supplied to deroyal by i.C.Medical.A supplier corrective action request (scar) was sent to the supplier september 30, 2019 as well as the returned samples for evaluation.In its response, i.C.Medical indicated it was unable to duplicate the reported complaint.From november 2017 to present, deroyal has sold 706 cases of finished good 88-000702.During this same period, a total of three complaints were received, yielding a complaint-to-sales ratio of 0.004.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: EXTENDEVAC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): I.C. MEDICAL, INC.; 15002 n. 25th dr.; phoenix AZ 85023
• MDR Report Key: 9238779
• Report Number: 2320762-2019-00011
• Device Sequence Number: 133217
• Product Code: GEI
• UDI-Device Identifier: 00749756157858
• UDI-Public: 00749756157858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K954088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 88-000702
• Device Lot Number: 49982316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1