MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Tachycardia (2095); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: the patient is (b)(6) male with basedow's disease.On (b)(6) 2020, the total thyroidectomy was performed for basedow's disease.Intraoperative nim confirmed preservation of the left recurrent laryngeal nerve.The right side was cut and anastomosed with the ansa cervicalis.A 15 fr drain was placed in the bilateral paratracheal regions.(no washing after spraying.) therefore, the patient had hoarseness after surgery.On (b)(6), aspiration due to drinking water (thickened water was ok, but aspiration due to normal water.) paroxysmal supraventricular tachycardia developed.(past medical history suspected).On (b)(6), the hoarseness was remarkable, and bilateral vocal cord fixation with laryngeal fiber, and tracheostomy was performed on the same day.(insert pp cannula) after that, the patient practiced drinking and eating.And regular meals and drinking water (thickened) was capable.Although confirmation of laryngeal fiber is final at (b)(6), bilateral vocal cord fixation will be continuously confirmed.((b)(6), there is no movement of the both sides of vocal cord in the dynamic images currently under way at the hospital.) currently, it is planned to change pp cannula to retina.What were the diagnosis and indication for the index surgical procedure? =>basedow's disease.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.No further information is available.Was there any intraoperative concurrent use of other products? a 15 fr drain was placed in the bilateral paratracheal regions.What is the lot number for the surgicel powder? no further information is available.What are the product code and lot number of the drain? no further information is available.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? for oozing around the nerve.What were current symptoms following the index surgical procedure? onset date? no further information is available.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative recurrent laryngeal nerve paralysis? no further information is available.9.What is the patient¿s current status? the patient has been hospitalized.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was noted an unknown blake drain was placed on (b)(6).What is the product code? were there any anomalies with the drain: appearance, damage or function? where was the drain placed? how was it secured? was the drain checked for patency during the procedure? did the drain function as intended? were any issues noted with the drain during use? when, on what date, was drain removed?.

Event Description

It was reported that a patient underwent a bilateral total thyroidectomy procedure on (b)(6) 2020 and absorbable hemostat was used.Bilateral recurrent laryngeal nerve paralysis occurred.Since there was oozing around the nerve, the absorbable hemostat was sprayed on the nerve part.The wound was closed without being washed away, which may have affected the wound.The absorbable hemostat has a large volume, and the surgeon used about 2g of it.There was a background of nerve anastomosis due to damage to the recurrent laryngeal nerve on the right side during surgery, to avoid paralyze of the left side, spraying was performed near the nerve where blood tends to come out, but the day after the surgery, both sides of the nerve were paralyzed.The patient is in a difficult situation and is still in the hospital.Since bilateral nerve palsy may cause suffocation, a tracheotomy was performed, and a meal has just started.The right nerve is damaged and will not return, but the surgeon thinks the left side will be able to move, and it is necessary to wait and see for at least half a year.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: it was noted an unknown blake drain was placed on feb.3.What is the product code? no further information is available.Were there any anomalies with the drain: appearance, damage or function? no further information is available.Where was the drain placed? the 15 fr drain was placed in the bilateral paratracheal regions.How was it secured? no further information is available.Was the drain checked for patency during the procedure? no further information is available.Did the drain function as intended? no further information is available.Were any issues noted with the drain during use? no further information is available.When, on what date, was drain removed? no further information is available.No further information will be provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 7/6/2021.Additional information was requested, and the following was obtained: the patient's nerve paralysis has recovered and is now able to speak.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11611863
• MDR Text Key: 260524244
• Report Number: 2210968-2021-02996
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR