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

Model Number	G30550
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 additional information 14 august 2017 "the cystotome arrived in the box damaged and therefore the product inside the box was bent and packaging had a hole due to the bent so was no longer sterile." the cst-10 device was returned unopened to cirl for an evaluation.A lab evaluation was held on 17 august 2017 on evaluation of the returned device, there was a hole on the front clear plastic side of the pouch.The customer complaint was confirmed based on visual inspection of the returned product which remained unopened.There was a visible hole/ tear on the clear plastic side of the pouch.It may be noted that the device would not have left the manufacturing facility in a damaged state.This issue would be detected during manufacturing if the damaged packaging was present during the time of manufacture; there are also regular burst tests completed as part of manufacturing to ensure this.The engineering representative stated that the most likely cause of the damaged packaging could be attributed to movement during handling or transport; however as the actual handling and transport conditions could not be replicated in the laboratory setting, the root cause of this complaint could not be conclusively determined.Cook ireland makes every effort to minimize the presence damaged packaging.The relevant production personnel in cirl have been notified of this complaint prior to distribution all cst-10 devices are subject to visual inspection to ensure device integrity.It may be noted that this observation was found prior to any patient contact and never reached the point of use.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
The packaging was torn and the product is desterilised.

• 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: 6824408
• Report Number: 3001845648-2017-00366
• Device Sequence Number: 13675588
• Product Code: KNS
• UDI-Device Identifier: 00827002305502
• UDI-Public: (01)00827002305502(17)200530(10)C1361973
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2017

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 Model Number: G30550
• Device Catalogue Number: CST-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1