MAUDE Adverse Event Report: A&E MEDICAL CORPORATION SUCTION COAGULATOR

Model Number	050-030
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint history for suction coagulators shows that there have been no prior complaints in the past 2 years regarding the tip of the suctional coagulator breaking off.This results in a complaint rate of (b)(4) (1 complaint per (b)(4) suction coagulators sold in the past 24 month period from the date this complaint was reported).The returned device was recently received; visual inspection confirmed that the bell tip was broken off from the body of the cannula as described by the customer.Further evaluation of the returned device will be conducted to investigate potential root cause.A closure report will be submitted once investigation is complete.
Event or Problem Description
The customer reported that the suction coagulator was ready to be used but before they could use it, the tip broke off.
Event or Problem Description
The customer reported that the suction coagulator was ready to be used but before they could use it, the tip broke off.
Additional Manufacturer Narrative
The complaint unit was returned by the customer and was investigated.Visual inspection confirmed that the bell tip of the cannula had broken off as reported by the complainant.Engineering evaluated the device by first measuring it and comparing it against the specifications for outer diameter, inner diameter, and wall thickness.It was found that the complaint unit was measured outside of specification for inner diameter, resulting in a slightly thicker wall.However, it is possible that this diameter was impacted by the break and does not necessarily point to a root cause for the failure.Next, various parts in production were inspected that could have introduced a failure.3 cannulas in production that had trimmed insulation were inspected and there appeared to be a light circular score mark in the cannula where the insulation had been trimmed.3 units of the plain brass cannula from raw material (prior to any processing) were also inspected and no score mark was observed.Lastly, 2 units of a final device, part 050-005 lot 119c, were inspected to confirm that scoring was present.To determine if scoring could be the root cause of the failure, 12 cannulas were bent to determine if the failure of the tip breaking off could be replicated.It was found that none of the cannulas broke when bent to ~90°.Additionally, when bent in excess of 9 lbs., the cannula tube began flattening and bent to ~180°.No amount of force was able to re-create the shear seen in the complaint unit.The supplier of the cannulas was contacted about this incident, and the returned unit was sent to the supplier after a&e's inspection.However, they were unable to provide any additional information pertaining to the investigation.In conclusion, a&e medical was not able to replicate the failure or determine the root cause of the tip breaking off.It is important to note that 29,890 suction coagulators were sold in the past 24 months from the date this complaint was reported (23dec2018 to 23dec2020), resulting in an occurrence rate of 0.003%.Also, there have been no other issues on this product lot from other customers.Production has not reported any in-process issues or seen any changes with manufacturing.Therefore, given the very low occurrence rate and the inconclusive results of the device evaluation, this event appears to be isolated with an undetermined root cause at this point in time.Should additional information be provided, further investigation will be conducted.

• Brand Name: SUCTION COAGULATOR
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; po box 758; farmingdale NJ 07727
• MDR Report Key: 11209706
• Report Number: 2242056-2021-00003
• Device Sequence Number: 2946847
• Product Code: GEI
• UDI-Device Identifier: 10841291104926
• UDI-Public: (01)10841291104926(10)01740(17)250701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K914193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: 050-030
• Device Catalogue Number: 050-030
• Device Lot Number: 01740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1