MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FT0021S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the incident sample was sent to biomedical innovations (bmed) for evaluation, however no failure mode was identified.The dhr indicated all operations were completed and properly signed off prior to lot release for shipment.Review of bmed nonconformance investigations (2015 ¿ present) and the older nonconforming material report records (2012 ¿ 2015) found no internal issues similar to that reported for this complaint.Visual examination of the storz cable ligasure plug and the two conductor cables between the plug and the storz cable, found no anomalies.No evidence of cable workmanship defects was found.Inspection of the storz connector found damage to the overmolded plastic in the area above and to the outside of the pin 1 receptacle.The damage appears to be melting of the connector plastic due to excessive heat and is consistent with other returned storz cables exhibiting similar damage to varying degrees in the pin 1 area.Due to the connector damage present and to ensure personnel safety, the normal production continuity/hipot test was not performed.Instead, a manual check of the cable continuity was performed using a fluke 70 iii multimeter.Results of the check found expected instances of continuity to still be present in the cable, despite the damage to the storz connect.Overall, this investigation found that the cables shipped by cea in lot x312 completed required testing and inspections, and met specified requirements.A source/cause for the excessive heat that resulted in the melted connector plastic cannot be determined.Bmed did not find any evidence that they caused the complaint issue.Root cause cannot be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the cable was burnt but no flame at the connector that plugs into the storz resectoscope to connect to our generator.Another cable was used to complete the procedure.There was no patient injury.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8384385
• Report Number: 1717344-2019-00269
• Device Sequence Number: 2228186
• Product Code: GEI
• UDI-Device Identifier: 20884521062082
• UDI-Public: 20884521062082
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 09/30/2023
• Device Model Number: FT0021S
• Device Catalogue Number: FT0021S
• Device Lot Number: X312X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 81