MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WRITEDOWN, SPIDER 2, TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	72203299W
Medical Device Problem Codes	Leak/Splash (1354); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the spider 2 was having vacuum problems in the pedal area.The device's arm moves with difficulty and there is a leak noise in the pedal.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product.The foot pedal assembly was heavily contaminated with a brown and white matter.A functional evaluation was performed.The foot pedal leaks air.The foot pedal does not de-pressurize the device.The reported complaint was confirmed and the root cause has been associated with a seal failure.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded that this was a repeat issue.

• Brand Name: WRITEDOWN, SPIDER 2, TENET 7615
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11555510
• Report Number: 1643264-2021-01115
• Device Sequence Number: 3932950
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: 885554029673
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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 Catalogue Number: 72203299W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1