MAUDE Adverse Event Report: DEPUY MITEK LLC US S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	227355
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown procedure the blade did not function.The procedure was completed with a second blade with no harm to the patient.During in-house engineering evaluation, it was determined that the suction tube on the device had residue.It was further determined that the device did not ablate nor coagulate.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated.The complaint can be confirmed.It was observed that the active tip of the device appeared activated and saline residue was present in the suction tubing indicating that the device had been previously used.The device was connected to a test generator to test the functionality of the device.The device was activated in both ablate and coagulate modes for several seconds, and neither were successfully activated.The device was forwarded to the manufacturer for further investigation into the observed failures.The manufacturer indicated that the active continuity of the device was out of specification.The handle of the devices was opened to further investigate the electrical defects.Upon opening it could be seen that the active wire had been trapped between the handle halves and sheared.The device as presented showed no active continuity.Root cause investigation has shown that the active wire had become trapped in the handle halves which resulted in the wire being sheared during the ultrasonic welding operation.A dhr review has been performed for the complaint device lot number u1712025; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Therefore no containment or correction action related to the individual complaint is required.At this point, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8585922
• Report Number: 1221934-2019-57055
• Device Sequence Number: 2346316
• Product Code: GEI
• UDI-Device Identifier: 10886705009732
• UDI-Public: 10886705009732
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 11/30/2020
• Device Catalogue Number: 227355
• Device Lot Number: U1712025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1