MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number	G35129
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device involved in this complaint was not available for return to cirl, therefore a document based investigation will be complete.Document review including ifu review: prior to distribution dt-6-5f are subjected to a visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for dt-6-5f of lot number c1624475 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1624475.As per instructions for use, ifu0026-10, notes section: ¿if an abnormality is detected that would prohibit proper working condition, do not use.¿ system preparation section: "with the endoscope tip straight, place the trigger cord into the slot on the spool of the multi-band ligator handle (gig.7a) and pull down until the knot is seated in the hole of the slot (fig.7b).Note: the knot must be seated into the hole or the handle will not function properly." "with the multi-band ligator handle in the two-way position, slowly rotate the handle clockwise to wind the trigger cord onto the handle spool until it is taut (fig.8).Note: care must be taken to avoid deploying a band while winding the trigger cord." there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause may be attributed to the trigger cord may not have been wound round the handle spool tightly enough and may have gotten caught up in a band when being deployed.Summary: complaint is confirmed based on customer testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As initially reported to customer relations: a patient underwent an emr- endoscopic mucosal resection procedure in which one duette multi-band mucosectomy device, g35129, was used.The bands were grabbing the string; the string was between the tissue and the bands.The physician was able to get three (3) bands around the tumor.Then removed the entire scope to cut the string to release.Then went down with a snare to release the tumor.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment - beaded string twisted'.No adverse effects to the patient have been reported as occurring.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Common Device Name: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8946178
• Report Number: 3001845648-2019-00446
• Device Sequence Number: 2521537
• Product Code: KNS
• UDI-Device Identifier: 00827002351295
• UDI-Public: (01)00827002351295(17)200617(10)C1624475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2020
• Device Model Number: G35129
• Device Catalogue Number: DT-6-5F
• Device Lot Number: C1624475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1