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

Model Number 227355

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: according to the information provided, it was reported that during a knee arthroscopy, when connecting a s50 3mm/50º suction electrode w/ integrated hand piece to the generator it does not function at all (could not coagulate and cut).The device was received and evaluated.Visual inspection revealed signs of activation, cable and connector showed no damage including the pins.Functional test was performed, on ablation and coagulate modes a warning signal appeared as "output shorted," therefore, the device was sent to the supplier for further evaluation.Supplier evaluation result for s50 sm.Dia.Electrode w/integ.Hndpiece-ea: the device was not returned in the original packaging, there are no obvious signs of use, saline residue visible in suction tube, no visible damage to the device shaft, handle, cable or plug.The electrical test was performed with the different parameters as a result the primary capacitance was fail.During functional test, the activation test ablation and coagulation mode were fail.Supplier summary: the investigation established the device function would vary between correct performance, and output short error.From our investigation we were able to confirm the customer reported defect of ¿output shorted¿ during testing of the returned device.Electrodes, which exhibit a similar defect have been further investigated through cap & cap.Both of these capas are now closed.Continuous review of complaints will be performed, and if any adverse trend is noted, a further review of this decision will be undertaken.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.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.

Event Description

It was reported by sales rep via complaint submission tool that during a knee arthroscopy, when connecting a s50 3mm/50º suction electrode w/ integrated handpiece to the generator it does not function at all (could not coagulate and cut).Another device was used to complete procedure.No surgical delay or patient consequence reported.No additional information could be provided.

• Brand Name: S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10605048
• MDR Text Key: 209127111
• Report Number: 1221934-2020-02807
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009732
• UDI-Public: 10886705009732
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 227355
• Device Catalogue Number: 227355
• Device Lot Number: U1901122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR