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

Model Number 88-000722

Device Problems Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (call 47698) was received indicating that an extendevac cautery pencil (part 88-000722) did not shut off when the generator was turned off.The defective sample was returned for evaluation.The pencil is supplied to (b)(4) by i.C.Medical.Therefore, a supplier corrective action request (scar) was sent to i.C.Medical as well as the defective sample.The investigation is ongoing at this time.This report will be updated when new and critical information is received.

Event Description

The extendevac pencil did not shut off when the generator was turned off.The product was in use during a procedure.

Event Description

The extendevac pencil did not shut off when the generator was turned off.The product was in use during a procedure.

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.In its response, i.C.Medical stated testing of the returned samples could not duplicate the reported failure of the pencil not shutting off.Two used samples and 25 representative samples were sent for evaluation.In one of the used samples, it was noted that the blue coag button would mechanically stick when pressed at a slight angle instead of pressing directly center.Despite this, the device did not remain activated nor did it unintentionally activate.All other samples also functioned normally.No issues with activation were observed.Corrective action: due to the investigation findings, no corrective actions are to be implemented at this time.Investigation summary: an internal complaint (b)(4)) was received indicating that an extendevac cautery pencil (part 88-000722) did not shut off when the generator was turned off.The defective sample was returned for evaluation.The pencil is supplied to deroyal by i.C.Medical.Therefore, a supplier corrective action request (scar) was sent to i.C.Medical as well as the defective sample.In its response, i.C.Medical indicated it tested the returned sample and was unable to confirm the complaint.From (b)(6) 2017 to present, deroyal has sold (b)(4) cases of finished good 88-000722.During this same period, a total of 5 complaints were received for this product, 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 WITH COATED BLADE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): I.C. MEDICAL, INC.; 15002 n. 25th dr.; phoenix AZ 85023
• MDR Report Key: 8894928
• MDR Text Key: 216598745
• Report Number: 2320762-2019-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00749756157919
• UDI-Public: 00749756157919
• Combination Product (y/n): N
• PMA/PMN Number: K954088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 88-000722
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1