MAUDE Adverse Event Report: COOK INC COPE GASTROINTESTINAL SUTURE ANCHOR SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	GIAS-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a percutaneous gastrostomy procedure, the anchor of gias-100 detached when the doctor applied traction to the suture, in order to pull the stomach wall close to the abdominal wall.They are waiting for the anchor to pass via the gi system.No additional information has been provided.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: a review of complaint history, device history record, drawings, instructions for use (ifu), manufacturing instructions, quality control and a functional test and visual inspection of the returned product was conducted during the investigation.The anchor and suture were inspected and found to be manufactured according to specification.The suture was pulled with minimal force and again with more than minimal force.However, the suture did not break and the suture did not pull from the anchor.The anchor was inspected and found to have adhesive in both ends of the anchor as shown in the drawing and described in the manufacturing instructions.There is no evidence to suggest that the device was not manufactured to specification.We are unable to determine the cause of the detachment reported by the customer in this complaint.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
During a percutaneous gastrostomy procedure, the anchor of gias-100 detached when the doctor applied traction to the suture, in order to pull the stomach wall close to the abdominal wall.They are waiting for the anchor to pass via the gi system.No additional information has been provided.

• Brand Name: COPE GASTROINTESTINAL SUTURE ANCHOR SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5615603
• Report Number: 1820334-2016-00254
• Device Sequence Number: 16223553
• Product Code: FGE
• UDI-Device Identifier: 00827002044746
• UDI-Public: (01)00827002044746(17)210111(10)6511799
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GIAS-100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2016
• Supplement Report FDA Received Date: 06/15/2016
• 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: Other