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

Catalog Number DT-MBM-6

Device Problem Failure to Deliver (2338)

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

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Rep (b)(4) phoned today and reported complaint.The customer has used a product, 1x dt-mbm-6 lot# c1582111, which has not yet been released for sales, so i am not able to log this on (b)(4).When in use on patient the threads of the rubber ligator got stuck between the resected area and the rubber band.The customer has kept the product to be returned."as per complaint form": the patient was refered to this hospital with a 1cm polyp in cardia where pad had shown low grade dysplasia.This was the indication for endoscopic resection.They marked the area as usual with diathermy and then mounted the duette system on the scope.The polyp was suctioned into the cap and a rubberband was released over it.At this moment one of the threads got stuck in the rubberband and they were stuck with one thread in a polyp with dysplasia.They solved the situation by releasing the rest of the rubber bands over the thread that was between the endoscope and the polyp, and then loosen the threads from the endoscope.They pulled out the endoscope and the threads were still left in the patient then.After this they could with some struggling use a snare and cut off the polyp that at this moment was embedded in a mess of threads and loose rubber bands.Then they could finish by catching the polyp threads and bands with a rothnet.Fda mdr reporting required: adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for "medical intervention" to remove the bands from the patient resulting in prolonged procedure time.No adverse effects to the patient have been reported as occurring.Additional information has been requested.Reportability re-assessment may be required on receipt of additional information.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Rep (b)(4) phoned today and reported complaint.The customer has used a product, 1x dt-mbm-6 lot#c1582111, which has not yet been released for sales, so i am not able to log this on esoks.When in use on patient the threads of the rubber ligator got stuck between the resected area and the rubber band.The customer has kept the product to be returned."as per complaint form": the patient was refered to this hospital with a 1cm polyp in cardia where pad had shown low grade dysplasia.This was the indication for endoscopic resection.They marked the area as usual with diathermic and then mounted the duett system on the scope.The polyp was suctioned into the cap and a rubberband was released over it.At this moment one of the threads got stuck in the rubberband and they were stuck with one thread in a polyp with dysplasia.They solved the situation by releasing the rest of the rubberbands over the thread that was between the endoscope and the polyp, and then loosen the threads from the endoscope.They pulled out the endoscope and the threads were still left in the patient then.After this thye could with some struggling use a snare and cut off the polyp that at this moment was embedded in a mess of threads and loose rubberbands.Then they could finish by catching the polypthreads and bands with a rothnet.Fda mdr reporting required: adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for "medical intervention" to remove the bands from the patient resulting in prolonged procedure time.No adverse effects to the patient have been reported as occurring.Additional information has been requested.Reportability re-assessment may be required on receipt of additional information.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the device was not returned therefore a document based review will be performed.Documents review including ifu review: prior to distribution dt-mbm-6 devices 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-mbm-6 of lot number c1582111 did not reveal any discrepancies that could have contributed to this complaint issue.The review of the relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.The device dt-mbm-6 of lot number c1582111 is the multi band ligator are component part of a duette device (dt-6-5f) which consist of two parts a snare component and a multi band ligator.The instructions for use, ifu0026-10, which accompanies this device instructs the end user to in step 4 ¿ maintain suction and deploy the band by rotating the multi-band ligator handle clockwise unit band release is felt, indicating deployment (fig.10) as above.Note: if the band will not deploy, place the handle in the two-way position and loosen the trigger cord slightly.Place the handle in the firing position and continue with the procedure.¿ it is at this point the user experienced an issue, they proceed to release out the remaining black rubber bands in one go over the barrel string and loosen the string and withdrew the endoscope.They went back in with the snare and gradually removed the strings and rubber bands and specimen with a rothnet.There is not sufficient evidence to suggest that the user did not follow the ifu.Root cause (possible): a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the beaded barrel string becoming tangled in the first black rubber band that was deployed.It is possible the beaded string was twisted during storage and/or transportation conditions of the device prior to use or as the result of damage during the preparation of the device prior to the procedure.As the device was not returned for evaluation it is not possible to definitely attributed the cause of this issue.Please see email attached ¿ (b)(4)_engineering input¿ summary: complaint is confirmed based on the customer¿s 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 Description

Rep (b)(6) phoned today and reported complaint.The customer has used a product, 1x dt-mbm-6 lot# c1582111, which has not yet been released for sales, so i am not able to log this on esoks.When in use on patient the threads of the rubber ligator got stuck between the resected area and the rubber band.The customer has kept the product to be returned."as per complaint form": the patient was refered to this hospital with a 1cm polyp in cardia where pad had shown low grade dysplasia.This was the indication for endoscopic resection.They marked the area as usual with diathermi and then mounted the duette system on the scope.The polyp was suctioned into the cap and a rubberband was released over it.At this moment one of the threads got stuck in the rubberband and they were stuck with one thread in a polyp with dysplasia.They solved the situation by releasing the rest of the rubberbands over the thread that was between the endoscope and the polyp, and then loosen the threads from the endoscope.They pulled out the endoscope and the threads were still left in the patient then.After this they could with some struggling use a snare and cut off the polyp that at this moment was embedded in a mess of threads and loose rubberbands.Then they could finish by catching the polypthreads and bands with a rothnet.Fda mdr reporting required: fda mdr report is required.Incident meets reporting criteria based on the requirement for "medical intervention" to remove the bands from the patient resulting in prolonged procedure time.No adverse effects to the patient have been reported as occurring.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8594922
• MDR Text Key: 144550159
• Report Number: 3001845648-2019-00198
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DT-MBM-6
• Device Lot Number: C1582111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention