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

Model Number	88-000702
Medical Device Problem Codes	Mechanical Problem (1384); Device Remains Activated (1525); Failure to Shut Off (2939); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 48634) was received for a smoke evacuation pencil (part 88-000702, lot 49503506) that failed during use.Specifically, the cauterization button became stuck int he "on" position.A sample initially was reported to be available for return.As of the date of this report, that sample has not been returned.The pencil is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).As of the date of this report, a response has not been received.The investigation is ongoing.When new and critical information is received, this report will be updated.
Event or Problem Description
The cauterization button got stuck in the "on" position.
Event or Problem Description
The cauterization button got stuck in the "on" position.
Additional Manufacturer Narrative
Root cause: the pencil is supplied to (b)(4) by i.C.Medical.Therefore, a supplier corrective action request (scar) was issued to i.C.Medical.In its response, the complaint could not be verified as no sample was ever provided for examination.However, preventive actions have been implemented as a result of similar complaints.Specifically, updates were made to i.C.Medical's button assembly procedure to include additional testing criteria for pass and fail, instruction of button verification after installation, and an update to the electrical test method to include verification of product activation or mechanical sticking when button is depressed on the upper or lower side.Investigation summary: an internal complaint (call (b)(4)) was received for a smoke evacuation pencil (part 88-000702, lot 49503506) that failed during use.Specifically, the cauterization button became stuck int he "on" position.A sample initially was reported to be available for return.(b)(4) made several attempts to retrieve the sample, but it ultimately was not returned for evaluation.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The pencil is supplied to (b)(4) by i.C.Medical.Therefore, a supplier corrective action request (scar) was issued to i.C.Medical.A response was received and accepted by (b)(4) personnel december 31, 2019.From november 2017 to present, (b)(4) has sold (b)(4) of finished good 88-000702.During this same time period, a total of three complaints were received, (b)(4).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 AZ 85023
• MDR Report Key: 9445851
• Report Number: 2320762-2019-00012
• Device Sequence Number: 19385493
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 49503506
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/10/2019
• 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