MAUDE Adverse Event Report: COOK IRELAND LTD GEENEN PANCREATIC STENT; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Koyabashi, 2019, geenen stent, the usefulness of wire-guided endoscopic snare papillectomy for tumors of the major duodenal papilla.A study of retrospectively examined data from 16 consecutive patients who underwent conventional endoscopic papillectomy (ep) between (b)(6) 1995 and (b)(6) 2005 and from 33 patients in whom wire-guided endoscopic papillectomy (wgep) was first attempted between (b)(6) 2005 and (b)(6) 2017.Pancreatic duct stenting and pancreatitis rates were compared between the two groups.Pancreatitis, cholangitis, peritonitis and bleeding were reported in patients who received a 5fr geenen pancreatic stent following papillectomy.Complaint#3: 10 cases bleeding following papillectomy and pancreatic duct stent placement.

Manufacturer Narrative

Device evaluation: the geenen devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.Documents review including ifu review: as the rpn and lot number is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution of geenen devices are subjected to a visual inspection and functional checks to ensure device integrity.The instructions of use (ifu0055-4) which would accompany 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.¿ 49 patients were involved in this study and according to the information 41 received geenen device.There were 10 cases of bleeding following papillectomy and pancreatic duct stent placement, requiring additional procedures.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the endoscopic papillectomy procedure.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, 10 cases of bleeding requiring additional procedures.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: GEENEN PANCREATIC STENT
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11301234
• MDR Text Key: 234424667
• Report Number: 3001845648-2021-00076
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male