MAUDE Adverse Event Report: CAREFUSION, INC TITAN BIPOL BAY FINE TIP .5MM STR FORCEP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number NL1552

Device Problem Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) 03dec2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.Kirwan surgical products, inc is the manufacturer of this 1p supplied product, and has been notified of this reportable event.Bd does not own the design, specification, or regulatory pathway for this product.

Event Description

Per medwatch: patient lip was burned during a base of tongue biopsy by the v mueller neuro/spine bi-polar forceps that was used for cautery during the procedure.Although we are just beginning to investigate, it appears that there was no issue with the instrument, but that the team did not realize the instrument being used was not insulated - had anticipated that only the forceps tip would be activated.We recommend consideration by the manufacturer to -possibly mark the packing more prominently that this instrument is not insulated.No further information available.Complaint number (b)(4) was opened and an initial mdr was submitted based on a medwatch # (b)(4) we received for the product listed in suspect medical device as product number ch6420.However, when clarified with the customer why it says ¿v mueller with the neuro/spine bi-polar forceps¿ in the description, she said that it was supposed to be submitted for nl1552 - titan bipol bay fine tip.5mm str forcep.We have opened complaint (b)(4) to capture the correct instrument of nl1552 and an mdr for this product will be submitted.Mfr report# 1423507-2020-00055 is the follow up mdr that was submitted for complaint # (b)(4) explaining the error regarding product number ch6420.03dec2020 additional information: the customer first mentioned on 20nov2020 that the forceps (nl1552) were in fact what was supposed to be reported instead of product # ch6420 referenced in complaint # (b)(4), and then it was confirmed on 23nov2020.

Manufacturer Narrative

Follow up 2135447.The device involved was not returned for evaluation.The three photos provided were of fairly poor condition (i.E., blurry) and did not reveal any relevant or useful information that could be used for a complaint evaluation.As stated in the event description, ¿it appears that there was no issue with the instrument, but that the team did not realize the instrument being used was not insulated - had anticipated that only the forceps tip would be activated.¿ based on this, it sounds like a (mis)use error, not under the manufacturer¿s control.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.The reported issue will continue to be trended and evaluated by bd.A review of the bd complaint system was performed for this instrument over the last two years.There have been no other reported complaints with the supplier for this reported issue.The reported issue will continue to be trended and evaluated by bd.

Event Description

Patient lip was burned during a base of tongue biopsy by the v mueller neuro/spine bi-polar forceps that was used for cautery during the procedure.Although we are just beginning to investigate, it appears that there was no issue with the instrument, but that the team did not realize the instrument being used was not insulated - had anticipated that only the forceps tip would be activated.We recommend consideration by the manufacturer to -possibly mark the packing more prominently that this instrument is not insulated.No further information available.

• Brand Name: TITAN BIPOL BAY FINE TIP .5MM STR FORCEP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10985102
• MDR Text Key: 220723362
• Report Number: 1423507-2020-00060
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403071751
• UDI-Public: (01)10885403071751
• Combination Product (y/n): N
• PMA/PMN Number: K811820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NL1552
• Device Catalogue Number: NL1552
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 59