MAUDE Adverse Event Report: UNKNOWN; GEX LASER INSTRUMENT, SURGICAL

Catalog Number UNKNOWN

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the tip of the laser fiber broke while inside the patient.At the end of the case, the circulating nurse asked the resident if he was going to try and retrieve the broken piece.The physician indicated that the tip broke off at an angle that is difficult to access.It broke into small pieces and there is no follow up procedure to retrieve it.No additional procedures are planned due to this occurrence.No adverse effects to the patient have been reported.Additional device, patient and event information has been requested but has not been provided at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation evaluation the device was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of specifications and quality control data was conducted.A review of the device history record was not able to be performed as the lot number and part number of the device was not provided.A review for additional complaints for the involved device was also not able to be completed without the device part number or lot number.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Due to the product not being returned, the part number and lot number of the device not being specified and the limited information about the event, the cause of the complaint is unknown.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation evaluation the device was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of specifications and quality control data was conducted.A review of the device history record was not able to be performed as the lot number and part number of the device was not provided.A review for additional complaints for the involved device was also not able to be completed without the device part number or lot number.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Due to the product not being returned, the part number and lot number of the device not being specified and the limited information about the event, the cause of the complaint is unknown.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNKNOWN
• Type of Device: GEX LASER INSTRUMENT, SURGICAL
• MDR Report Key: 7313343
• MDR Text Key: 101593282
• Report Number: 1820334-2018-00458
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR