MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number	G30550
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
After using the needle knife the nurse wants to remove the needle knife from the device.This was nearly impossible.Starting to remove she felt a stronger friction than usual.And at the end (handle) there was a strong resistance, which resulted in destruction of the device, the procedure could be completed with a second device from the same lot without problems.This instrument was disposed of.
Event or Problem Description
After using the needle knife the nurse wants to remove the needle knife from the device.This was nearly impossible.Starting to remove she felt a stronger friction than usual.And at the end (handle) there was a strong resistance, which resulted in destruction of the device, the procedure could be completed with a second device from the same lot without problems.This instrument was disposed of.
Additional Manufacturer Narrative
Pma/510(k) #k022595 investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
The cst-10 device of lot number c1603418 involved in this complaint was not was not available for evaluation.With the information provided, a document based investigation was conducted.Prior to distribution all cystotome cst-10 devices are subject to 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 relevant manufacturing records (b)(4) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has occurred previously with this lot number.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined.A possible root cause could be attributed to the handle and male luerlock adapter could have been over-tightened causing the o-ring to pinch the tubing.The complaint is confirmed based on customer testimony.According to the initial reporter, 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
After using the needle knife the nurse wants to remove the needle knife from the device.This was nearly impossible.Starting to remove she felt a stronger friction than usual.And at the end (handle) there was a strong resistance, which resulted in destruction of the device, the procedure could be completed with a second device from the same lot without problems.This instrument was disposed of.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
After using the needle knife the nurse wants to remove the needle knife from the device.This was nearly impossible.Starting to remove she felt a stronger friction than usual.And at the end (handle) there was a strong resistance, which resulted in destruction of the device, the procedure could be completed with a second device from the same lot without problems.This instrument was disposed of.
Additional Manufacturer Narrative
This is a correction report as the investigation has been updated to reflect changes to the root cause summary previously submitted under emdr 3001845648-2019-00397.Device evaluation: the cst-10 device of lot number c1603418 involved in this complaint was not was not available for evaluation.With the information provided, a document based investigation was conducted.Document review : prior to distribution all cystotome cst-10 devices are subject to 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 relevant manufacturing records (c1603418) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has occurred previously with this lot number(reference (b)(4) - emdr ref # 3001845648-2019-00398).Reference (b)(4).There is no evidence to suggest that the customer did not follow the instructions for use (ifu0005-11).Root cause review: as the device was not returned it can not be confirmed if the root cause established in ncr19-051 is applicable however it is possible.As per nc19-051 investigation, engineering have determined the root cause is attributed to the outer diameter (od) of external handle threads being too large (out of specification).Due to this od being too large; post assembly of mlla adapter rmn 25-099 onto the threads of handle, the mlla is applying localized pressure to this location.This pressure is squeezing on the o-ring that sits under the mlla onto the inner catheter causing it to pinch resulting in difficulty in movement of the inner wire (needle knife section) past this pinched point.Summary : the complaint is confirmed based on customer testimony.According to the initial reporter, 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
This is a correction report as the investigation has been updated to reflect changes to the root cause summary previously submitted under emdr 3001845648-2019-00397.After using the needle knife the nurse wants to remove the needle knife from the device.This was nearly impossible.Starting to remove she felt a stronger friction than usual.And at the end (handle) there was a strong resistance, which resulted in destruction of the device, the procedure could be completed with a second device from the same lot without problems.This instrument was disposed of.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Common Device Name: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8873495
• Report Number: 3001845648-2019-00397
• Device Sequence Number: 11451946
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)220410(10)C1603418
• Combination Product (Y/N): N
• PMA/510(K) Number: K022595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/18/2020

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: 04/10/2022
• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Device Lot Number: C1603418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019; 07/11/2019; 07/11/2019; 07/10/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/05/2019; 10/03/2019; 10/31/2019; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1