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

Model Number G30550

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to customer relations "the doctor used a 19g cook echotip ultra needle to puncture the cyst.He then proceeded to place a 450cm jagwire.An exchange was performed leaving the wire in place.He then proceeded to remove the zimmon needle knife and plastic 5f catheter from the cystotome.The 10f diathermic ring was then advanced over the pre-positioned wire.He then positioned the endothermic using fluoroscopy.This was also confirmed when resistance was felt while pushing the 10f catheter.The erbe machine was set to ¿endocut¿ 100 watts.While pushing on the peddle, the doctor commented that no current was delivered to the diathermic ring.He continued for about a minute or so.Visually, no burning was seen either.He then removed the cystotome and decided to dilate the opening with a 12mm balloon.He then completed the case with placing two wires and 2 zimmon 7f,7cm double pigtail stents.The erbe machine was confirmed to be working as subsequent ercps were ok.".

Manufacturer Narrative

510(k) number: k022595.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Importer site establishment registration number:(b)(4).Device evaluation: the cst-10 device of c1468295 lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2018.On evaluation of the returned device, no issues detected with returned device.Inner catheter and knife were missing.Visual inspection was completed.Device dismantled to check inner wire connected to the electrode of one black adapter.No issue noted.Also checked to see if inner wire connected to diathermic ring.No issues noted.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Root cause: a definitive root cause for the customer complaint was determined as the physicians used an eus needle (in this case echo-19) to puncture the cyst.The user planned to use the eus needle first and then use only the black outer catheter of the cystotome to enlarge the puncture site.When that didn't work, the physician used a balloon instead.Therefore the user didn't follow the steps of the ifu and he didn't use the needle knife to make the initial puncture.The diathermic ring came in direct contact with the guide wire, grounding may have occurred preventing current being transferred to the ring.In the ifu we advise to leave the inner 5fr catheter in place to prevent direct contact with the diathermic ring and the wire.The device outer catheter is not intended to be advanced on its own over a wire guide.Our ifu has the warning ¿to avoid electric shock, ensure the ring does not come in contact with wire guide¿.In this case the jagwire used would likely not have caused grounding but we would have no testing to support this.There are many user related factors which could have resulted in the failure of the diathermic ring to heat such as incorrect grounding pad placement, incorrect connection of grounding pad to esu, incorrect connection of device to esu, incorrect active cord used, damaged active cord used, incorrect esu settings used.It¿s impossible for us to say exactly what occurred to cause this issue but one thing is for sure the user did not follow the ifu.Documents review: a review of the manufacturing records for the device of lot #c1468295 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1468295 ; upon review of complaints this failure mode has not occurred previously with this lot #c1468295.Ifu review: it may be noted that according to instructions for use, the user is instructed to: ¿to avoid electric shock, ensure the ring does not come in contact with wire guide¿ there is evidence to suggest that the customer did not follow the instructions for use.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.There was no impact to the patient or end user.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations "the doctor used a 19g cook echotip ultra needle to puncture the cyst.He then proceeded to place a 450cm jagwire.An exchange was performed leaving the wire in place.He then proceeded to remove the zimmon needle knife and plastic 5f catheter from the cystotome.The 10f diathermic ring was then advanced over the pre-positioned wire.He then positioned the endothermic using fluoroscopy.This was also confirmed when resistance was felt while pushing the 10f catheter.The erby machine was et to ¿endocut¿ 100 watts.While pushing on the peddle, the doctor commented that no current was delivered to the diathermic ring.He continued for about a minute or so.Visually, no burning was seen either.He then removed the cystotome and decided to dilate the opening with a 12mm balloon.He then completed the case with placing two wires and 2 zimmon 7f,7cm double pigtail stents.The erby machine was confirmed to be working as subsequent ercps were ok.".

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7761065
• MDR Text Key: 116869509
• Report Number: 3001845648-2018-00369
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)210329(10)C1468295
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: G30550
• Device Catalogue Number: CST-10
• Device Lot Number: C1468295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR