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

Catalog Number CST-10

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Needle seized up when taking it out."as per cc form": after make initial incision with.038¿ needle knife in the 5 fr catheter, the needle knife seized up when taking it out.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence patient/event info - notes: are images of the device or procedure available? n/a, yes, no.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? n/a, handle end, patient end no, in straight position.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.What scope was used? what esu was used? was the wire guide placed during the procedure? is it possible to advance outer catheter into cyst? what electrosurgical unit was used? what watt was this set to? please advise the anatomical location of the intended target site.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the return and evaluation of the complaint device on (b)(6) 2022: visual inspection: - distal coil of needle knife found to be uncoiled\damaged.- kink observed below the male leur lock adapter of the handle functional inspection: - n/a no impact to ae assessment.Follow up report scheduled.

Manufacturer Narrative

Device evaluation the cst-10 device of lot number c1870769 involved in this complaint was returned evaluation with the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Clarification requested 28th mar 2022 ¿¿ following lab evaluation of the cst-10 device a kink in the inner catheter was observed.Can we please request if this kink was observed prior to use of the device? ¿¿ clarification received 25th apr 2022¿¿ after discussion with the user, she cannot confirm if this kink was present prior to use of the device.¿¿ lab evaluation the device related to this occurrence underwent a laboratory evaluation on 04 mar 2022.The distal coil of needle knife was found to be uncoiled\damaged.A kink was observed below the male leur lock adopter of the handle.Document review prior to distribution, all cst-10 devices are subjected to functional checks and 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 cst-10 of lot number c1870769 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 c1870769.The instructions for use, ifu0005 which accompanies this device, instructs the user to; "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 definitive root cause could not be determined from the available information.A possible root cause of the kink is excessive force pulling against a resistance.It is possible the elevator was closed while carrying out the procedure.The kink would have made removing the coiled wire difficult and excessive force to remove it would have resulted in the uncoiling of the wire.Summary complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13583814
• MDR Text Key: 296405261
• Report Number: 3001845648-2022-00100
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 10827002305509
• UDI-Public: (01)10827002305509(17)240923(10)C1870769
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Device Lot Number: C1870769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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