MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	G22181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k171619.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Reported by the dm on behalf of the customer's email - upon removal of wire at the inner cannula the inner cannula broke.All product was removed from the patient no injury.Product was discarded due to soiled condition.The following has been requested- (b)(4).02mar2022.Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Did the patient require any additional procedures due to this occurrence? did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? the following has been requested- (b)(4) 02mar2022 was the device flushed before use? n/a, yes, no 1.1.2 what was flushed through the device (water, saline, etc.)? n/a, water, saline, other if other please specify.1.1.3 was lubrication applied to the decompression tube? n/a yes, no.1.1.4 details of the wire guide used (diameter, type, make)? 1.1.5 if not with the device in question, how was the procedure finished? 1.1.6 please advise the anatomical location of the intended target site.1.1.7 how experienced was the physician with using the cdsg? 1.1.8 did the patient require any additional procedures as a result of this event? n/a, yes, no.1.1.9 what intervention (if any) was required? 1.1.10 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 1.1.11 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.1.1.12 what is the endoscope manufacturer and model number that was used? 1.1.13 was resistance encountered when advancing the decompression tube into position? n/a, yes, no.1.1.14 if resistance was encountered, was the endoscope withdrawn a short distance? n/a, yes, no.1.1.15 how often was the decompression tube irrigated? 1.1.16 did any section of the device detach inside the endoscope or patient? n/a, yes, no.1.1.17 how long was the set left in dwelling?.
Event or Problem Description
Supplemental report is being submitted due to completion of the investigation.
Additional Manufacturer Narrative
Pma/510(k) # k171619.Device evaluation: 1 x cdsg-14-175 of lot number c1851698 involved in this complaint was not available for evaluation.Document review including ifu review: prior to distribution cdsg-14-175 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 cdsg-14-175 of lot number c1851698 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 c1851698.The instructions for use states the following: ¿if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ root cause review: a definite root cause cannot be determined as the device was not returned and due to limited information.Engineering input received stated that it could be a guiding catheter issue as the break occurred after the removal of the wire guide.Several attempts have been made to obtain additional information and if the black catheter broke but this information has not been forthcoming, if it is received at a later date the investigation will be updated accordingly.Summary: complaint is based on customer testimony.According to the information reported, all product was removed from the patient and there were no adverse effects.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: COLON DECOMPRESSION SET
• Common Device Name: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13937514
• Report Number: 3001845648-2022-00179
• Device Sequence Number: 19834314
• Product Code: FEG
• UDI-Device Identifier: 00827002221819
• UDI-Public: (01)00827002221819(17)240720(10)C1851698
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 07/20/2024
• Device Model Number: G22181
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: C1851698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown