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

Model Number	G30550
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k022595.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 or Problem Description
Cystotome creates a fistula between the stomach and the pancreatic duct.This device could not be set up on the guide because of a significant friction.Further abnormal difficulty for removal of the internal stylet and removal of the guide in place.Renewal with a second dm identical guide) under the same conditions went smoothly.Patient injury to be confirmed.
Event or Problem Description
Cystotome creates a fistula between the stomach and the pancreatic duct.This device could not be set up on the guide because of a significant friction.Further abnormal difficulty for removal of the internal stylet and removal of the guide in place.Renewal with a second dm identical guide) under the same conditions went smoothly.Patient injury to be confirmed.
Additional Manufacturer Narrative
Pma/510(k) # k022595.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: 1 x cst-10 of lot number c1545960 was returned to cirl for evaluation opened in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2019.The inner catheter was observed to be crumpled and it was noted that 2 stylets were returned with the device.The following information was requested post lab evaluation: ¿what size wire guide was used? was the cystome advanced over a pre-positioned wire guide?¿ to which the reporter responded: ¿the size of the wire is 0,35¿ and cystotome advanced on the wire guide¿ image review: n/a.Document review including ifu review: prior to distribution cst-10 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 cst-10 of lot number c1545960 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 c1545960.As per the instructions for use, ifu0005-9, step 10: ¿note: before each introduction of a wire guide into a device, wet wire guide in a sterile water or saline bath.A contrast filled catheter may make wire guide difficult to advance.Flush contrast from catheter with water or saline before each introduction of wire guide.Advance wire guide into pancreatic pseudocyst to facilitate the introduction of a stent or drainage set¿.Root cause review: a definite root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory.A possible contributing factor to the issues encountered may be due to user error.It was confirmed that the cystome was onto a prepositioned wireguide.Advancing the device into the endoscope over a prepositioned wire guide is not following the procedural steps outlined in the ifu.As per information provided: ¿i examined it and it turns out that the catheter is deformed and a little melted.It seems to me that this is a misuse of the product by operators.¿ summary: complaint is confirmed as based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.As per information provided, there were no adverse effects on the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 8423873
• Report Number: 3001845648-2019-00106
• Device Sequence Number: 19375810
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)211004(10)C1545960
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 10/04/2021
• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Device Lot Number: C1545960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening