MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; CANNULA, SURGICAL, GENERAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Tachycardia (2095); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product used in this procedure? citation: interactive cardiovascular and thoracic surgery 16 (2013) 718¿720; doi:10.1093/icvts/ivt047.(b)(4).

Event Description

It was reported via journal article "title: haemothorax following bullectomy caused by a sharp edge of the endoloop".Author(s): hajime otsuka, yoshinobu hata*, keigo takagi and fumitomo sato.Citation: interactive cardiovascular and thoracic surgery 16 (2013) 718¿720; doi:10.1093/icvts/ivt047.This report aimed to present a (b)(6) year-old male patient who underwent bullectomy for left spontaneous hemothorax in which endoloop was used in resection of the remaining small part of the lung at an earlier staple bullectomy.This patient presented with severe left chest pain, lost consciousness, tachycardia, pallor and hypotension (blood pressure of 80/50mmhg).He received lactated ringer¿s solution resulted in blood pressure recovery to 114/95mmhg, heart rate of 104bpm.After stabilization, blood examination and chest ct revealed left hemothorax.A thoracostomy tube was inserted which drained 1500ml of fresh blood.He then had emergency thoracoscopic surgery 3h after admittance.Thoracoscopic examination revealed massive blood clot and upon its removal, an ongoing bleeding from a small ulceration on the chest wall could be seen which might have temporarily stopped or reduced by being covered with the blood clot and because of hypotension.The lesion was then clipped and covered using a collagen patch coated with human fibrinogen and thrombin.The protruding sharp edge of endoloop was excised together with the surrounding tissue using a stapler.The postoperative course was uneventful and he was discharged 5 days later.It was suspected that the ulceration was caused by cuts from the sharp edge of the endoloop that had been used to resect the remaining small part of the lung at the earlier staple bullectomy.Awareness of this potential problem may help in preventing such extremely rare complications.

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/27/2018.Corrected information: this medwatch report is being voided as it is a duplicate of medwatch report # 2210968-2013-05791.Please see medwatch report # 2210968-2013-05791 for all information regarding this event.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8197598
• MDR Text Key: 131481559
• Report Number: 2210968-2018-78037
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 12/27/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR