MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC DC EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	DC EXTENSION CABLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The getinge's account manager reported tears in the dc extension cable while he was using it during leg model training.No patient was involved.
Additional Manufacturer Narrative
Trackwise (b)(4).Updated section: b4, d4, g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the lot # p18j04-04 the vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.Historical data analysis: (4109/213/67)the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period mar 2020 through feb 2022 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 /13 & 22) enter investigation findings: the device was returned to the factory for evaluation on 02/28/2022.A photograph was provided by the account.A photographic inspection was conducted.No signs of clinical use or evidence of blood was observed due to the product observed inside the product packaging.An investigation was conducted on 03/02/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There cable ends were observed to be intact.No visual defects on the cables ends were observed.There visual cuts in the body of the cable, exposing the inside of the cable.No other visual defects were observed.Based on the returned condition of the device and the investigation results, the reported failure " material integrity problem|material split, cut or torn" was confirmed.
Event or Problem Description
N/a.

• Brand Name: DC EXTENSION CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 13712226
• Report Number: 2242352-2022-00213
• Device Sequence Number: 17504824
• Product Code: GEI
• UDI-Device Identifier: 00607567700888
• UDI-Public: 00607567700888
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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 Model Number: DC EXTENSION CABLE
• Device Catalogue Number: VH-3030
• Device Lot Number: P18J04-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown