MAUDE Adverse Event Report: CONMED CORPORATION BICAP HEMOSTASIS PROBE 7FR; ELECTRODE, FLEXIBLE SUCTION COAGULATOR

Catalog Number BP-7300A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported an issue involving the bp-7300a, bicap hemostasis probe 7fr, lot # 201810081 that occurred at the digestive disease center in (b)(6) on (b)(6) 2020.It was reported that the "probe tip detached which exposed wires at distal tip" during use in surgery.It is also noted the procedure was successfully completed using another probe and there was no impact or injury to the patient.Although multiple requests have been made, to date, no additional information or clarification has been made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the tip detached during use.

Manufacturer Narrative

Additional information was provided by the reporter.Despite attempts over the past month to obtain the device for return to conmed for evaluation, the device has not been located or returned to conmed by the facility.Its location is unknown.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.Should the device be returned an evaluation will be performed and upon completion of the complaint investigation a supplemental and final report will be filed.The manufacturing documents from the device history record and lot history records have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame 4,156 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0005.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user that care should be taken not to damage the probe while advancing it through a scope tip bent 15 degrees or more.The ifu also advises the user that these devices should be inspected before use and discarded if compromised.Visually examine the devices for obvious physical damage and do not use if damage is found: cracked, broken or otherwise distorted plastic parts, broken or significantly bent shaft or connector contacts, opened, damaged or compromised package.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional information provided by the reporter indicates the technician and the doctor were using the bicap hemostasis probe on an avm.When they removed it to wipe the tip off, the whole tip fell came off.Since they could see the wires, they grabbed another bicap and proceeded to treat the patient.Although requested, this was the only additional information made available.

Manufacturer Narrative

The product in question was returned to conmed for evaluation.The reported complaint of the probe tip detached exposing wires at the distal tip is now confirmed.An examination of the returned used device, bp-7300a, quantity of 1, found there are exposed wires at the distal end of the device where the probe is attached.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user that care should be taken not to damage the probe while advancing it through a scope tip bent 15 degrees or more.The ifu also advises the user that these devices should be inspected before use and discarded if compromised.Visually examine the devices for obvious physical damage and do not use if damage is found: cracked, broken or otherwise distorted plastic parts, broken or significantly bent shaft or connector contacts, opened, damaged or compromised package.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BICAP HEMOSTASIS PROBE 7FR
• Type of Device: ELECTRODE, FLEXIBLE SUCTION COAGULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10295762
• MDR Text Key: 200408269
• Report Number: 1320894-2020-00306
• Device Sequence Number: 1
• Product Code: FEH
• Combination Product (y/n): N
• PMA/PMN Number: K803214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Catalogue Number: BP-7300A
• Device Lot Number: 201810081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1