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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE

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COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Perforation (2001); No Code Available (3191)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
Procode: kns unit, electrosurgical, endoscopic. (b)(4).
 
Event Description
Per journal article: risk factors for serious adverse events associated with multiband mucosectomy in barrett¿s esophagus: an international multicenter analysis of 3827 endoscopic resection procedures. Belghazi et al. 2020. Perforation - perforation occurred in 17 out of 3,827 procedures accounting for a perforation rate of 0. 4% (95% ci, 0. 3 ¿ 0. 7) the vast majority of patients (14/17) could be treated endoscopically with clips (n
=
11) or a combination of clips and a stent (n
=
3). The endoscopically and conservatively treated patients were admitted for a median of 4 days (iqr 1 ¿ 5), and all cases were considered to be mild (n
=
7) or moderate (n
=
8) adverse events. In one patient clipping was not successful due to poor tissue grasping. This patient was therefore treated conservatively with antibiotics. Two patients ) were referred for surgery; both were graded as severe adverse events. In the first patient, er was performed because of a local recurrence after a large er. During the procedure, a perforation occurred within the previous er site. Because there was clear evidence of residual neoplasia, the decision was made to perform an emergency esophagectomy as local control of the disease was not achieved. In one patient clipping was not successful due to poor tissue grasping. This patient was therefore treated conservatively with antibiotics. Two patients) were referred for surgery; both were graded as severe adverse events. In the first patient, er was performed because of a local recurrence after a large er. During the procedure, a perforation occurred within the previous er site. Because there was clear evidence of residual neoplasia, the decision was made to perform an emergency esophagectomy as local control of the disease was not achieved. In the second patient, a perforation was observed immediately after the first resection. Because of the combination of residual neoplasia and periesophageal scarring after prior surgery for placement of an angelchik prosthesis, endoscopic treatment was not considered and the patient underwent an esophagectom. The data from this paper was obtained from 7 countries 7 countries ((b)(6), united states) as an exact location cannot be determine for the complaints, a complaint has been originated for each location.
 
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Brand NameDUETTE MULTI-BAND MUCOSECTOMY DEVICE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10078586
MDR Text Key193022852
Report Number3005580113-2020-00363
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/20/2020,05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/23/2020
Event Location Hospital
Date Report to Manufacturer05/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/21/2020 Patient Sequence Number: 1
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