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

Model Number G34036

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

The dt-6 device of lot number c1610237 involved in this complaint device involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory on 25th october 2019.The trigger cord was found tangled.No visual defects on loading catheter.The trigger cord was untangled and no defect observed on cord.Prior to distribution all dt-6devices are subjected to a visual inspection and functional checks 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 device of lot number c1610237 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1610237; upon review of complaints this failure mode has not occurred previously with this lot #c1610237.The instructions for use (b)(4) which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest that the customer did not follow the instructions for use.From the information provided " so knot was on trigger cord which used for deploy bands." (ref.Att."pr 275454_additional information_29th oct 2019").A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to transportation or device handling during preparation.As per engineering input ".The string does have some knots by design".Therefore, it is difficult to establish at what point the trigger cord became tangled.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence (prior to use).Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As per esoks translation: default of the duette kit; there was a knot on the wire guide."as per complaint form": prior to use, there was a default of the duette kit, there was a knot on the trigger cord.The device involved in the complaint was evaluated in the laboratory on 25th october 2019.The trigger cord was found tangled.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'.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick
• MDR Report Key: 9350900
• MDR Text Key: 219773748
• Report Number: 3001845648-2019-00616
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002340367
• UDI-Public: (01)00827002340367(17)200426(10)C1610237
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2020
• Device Model Number: G34036
• Device Catalogue Number: DT-6
• Device Lot Number: C1610237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1