MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SUCTION COAG,F/S,10FR; SUCTION COAGULATOR

Model Number	130187
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, photographic inspection of a device photo exhibited insulation failure.A potential cause for the observed failure could be bending stress combined with excessively high temperatures.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number, 2,700 pieces manufactured, showed no other complaint for this lot product and event description.A two-year review of complaint history revealed one other similar complaint for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent.The instructions for use advises the user that these devices should never be used when: - there is visible evidence of damage to the exterior of the device such as cuts, punctures, nicks, abrasions, unusual lumps, or significant discoloration.- in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide, or in oxygen-enriched environments.- where conventional monopolar electrosurgery is inappropriate or unsafe, such as for small appendages, in circumcision or finger surgery.The user is also advised of the following: - use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that during a procedure, the 130187 suction/coagulation insulation coating split.No surgical delays or patient injury were reported.To date, no additional information regarding patient status or procedure has been made available.This incident is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: SUCTION COAG,F/S,10FR
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7522894
• Report Number: 3007305485-2018-00103
• Device Sequence Number: 19239122
• Product Code: GEI
• UDI-Device Identifier: 30653405059930
• UDI-Public: (01)30653405059930(17)221204(10)201712054
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 12/04/2022
• Device Model Number: 130187
• Device Catalogue Number: 130187
• Device Lot Number: 201712054
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1