MAUDE Adverse Event Report: COOK INC COOK CUTTING LOOP; GEI UNIT, ELECTROSURGICAL AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the cutting loop device used during a transureteral resection of a bladder tumor broke off in the patient and was removed with the rigid grasper.The physician used a third device from a different lot number to complete the procedure.There was no harm to the patient, no additional procedures required.The patient was doing well post procedure.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, complaint history, documentation, instructions for use (ifu), quality control, visual inspection and specifications was conducted during the investigation.The device was returned for evaluation.Physical examination of the returned device was performed and as per the supplier's evaluation no anomalies were noted for this device lot.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and one non-conformance was noted, however this non-conformance was not related to the reported failure.Ifu was supplied with the each device which states the proper warnings, precautions, and instructions for use.The ifu also states ¿do not bend or change the angle or shape of the distal end.To do so may cause poor function, damage to the resectoscope and injury to the physician and/ or the patient.Immediately discontinue use if break or fractures appear in the device.These conditions may allow undirected emission of electrical energy, rendering the device useless and potentially causing harm to surrounding tissues.Do not use if there are breaks, scratches, and cracks in the insulation on the electrode.Use of the electrode with damaged insulation may cause unintended electrosurgical burns.Care should be taken to avoid severe impacts, side stresses or bends at sharp angles.¿ based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: COOK CUTTING LOOP
• Common Device Name: GEI UNIT, ELECTROSURGICAL AND ACCESSORIES
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6074172
• Report Number: 1820334-2016-01197
• Device Sequence Number: 76192
• Product Code: GEI
• UDI-Device Identifier: 00827002462090
• UDI-Public: (01)00827002462090(17)190725(10)7145935
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2017

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 Model Number: N/A
• Device Catalogue Number: CL-2412-AC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 06/14/2017
• 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: Required Intervention