DUETTE MULTI-BAND MUCOSECTOMY
Report
- Report Number
- 3001845648-2025-00183
- Event Type
- Injury
- Date Received
- April 10, 2025
- Date of Event
- September 3, 2024
- Report Date
- May 15, 2025
- Manufacturer
- COOK MEDICAL IRELAND
- Product Code
- KNS
- PMA / PMN Number
- K050578
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE DUETTE MULTIBAND MUCOSECTOMY DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO A LITERATURE STUDY (B)(6). MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0026) LISTS ¿PERFORATION¿ AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO THE DEVICE OR THE PROCEDURE. AS PREVIOUSLY NOTED, "PERFORATION" IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01 X USED DEVICE. CORRECTIVE ACTION/CORRECTION COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS COMPLAINT WAS OPENED FROM LITERATURE STUDY ¿RECURRENCE FOLLOWING SUCCESSFUL ERADICATION OF NEOPLASIA WITH ENDOSCOPIC MUCOSAL RESECTION COMPARED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION IN BARRETT¿S ESOPHAGUS: A RETROSPECTIVE COMPARISON¿ TO CAPTURE 01 CASE OF PERFORATION. IT IS LIKELY THAT INTERVENTION/ADDITIONAL PROCEDURES WOULD HAVE BEEN REQUIRED AS A RESULT OF THIS OCCURRENCE.
YUSUKE FUJIYOSHI, 2024,RECURRENCE FOLLOWING SUCCESSFUL ERADICATION OF NEOPLASIA WITH ENDOSCOPIC MUCOSAL RESECTION COMPARED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION IN BARRETT¿S ESOPHAGUS: A RETROSPECTIVE COMPARISON. DESCRIPTION OF PROCEDURE: ENDOSCOPIC RESECTION (EMR) PROTOCOL WAS CARRIED OUT USING THE MULTIBAND LIGATION TECHNIQUE, UTILIZING A THERAPEUTIC GASTROSCOPE (GIF-1T190; OLYMPUS CO., TOKYO, JAPAN) AND DUETTE MULTIBAND MUCOSECTOMY DEVICE (COOK MEDICAL INC., BLOOMINGTON, INDIANA, USA). ESD WAS CARRIED OUT UTILIZING A GASTROSCOPE (GIF-HQ190; OLYMPUS CO.) FITTED WITH A SOFT PLASTIC CAP.VOLUVEN (FRESENIUS KABI AG, BAD HOMBURG, GERMANY) WITH METHYLENE BLUE WAS INJECTED SUBMUCOSALLY. INCISION, DISSECTION, AND HAEMOSTASIS WERE PERFORMED WITH DUALKNIFEJ AND COAGRASPER (OLYMPUS CO.), AND ELECTROSURGICAL GENERATOR (VIO-300 D, ERBE USA INC., MARIETTA, GEORGIA, USA). MALFUNCTION/INJURY: PERFORATION. THIS FILE WILL CAPTURE 1 CASES OF PERFORATION WHICH LIKELY REQUIRED INTERVENTION/ADDITIONAL PROCEDURES. EMR WAS CARRIED OUT USING THE MULTIBAND LIGATION TECHNIQUE ON 87 PATIENTS. SEX: MALE: 68 (78.2%) FEMALE: 19 (20.8%) AGE: 70.1 MEAN (10.6).
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-APR-2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416578 | DUETTE MULTI-BAND MUCOSECTOMY | KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC | KNS | COOK MEDICAL IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |