MAUDE Adverse Event Report: TIDI PRODUCTS LLC DRAPE, C-ARM 6600/6800, 48X84; DRAPE, SURGICAL

Model Number	5403
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
4/69/24-lk complaint #ot-149 before procedure, partially torn drape was found when opening the package.As a result of the returned sample(s) review at gmkk: the torn drape, 37cm long(14.5" long), was confirmed.
Additional Manufacturer Narrative
H3: the complaint product will not be returned.Therefore, this report is based solely on customer provided information.The dhr was reviewed and found no issues noted during production.Historical complaint data review identified one other complaint for holes/tears for this product family in the last 2 years, however the complaint could not be confirmed after evaluation of return samples.This failure mode and product family has a complaint rate of 0.004% based the last 2 years of sales data.With the information available the root cause could not be determined.The operators at the manufacturing site were provided awareness training on this complaint as a precaution.This failure mode has a very low complaint rate, therefore no further corrective or preventative actions are necessary at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file: (b)(4).

• Brand Name: DRAPE, C-ARM 6600/6800, 48X84
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 19274208
• Report Number: 2182318-2024-00060
• Device Sequence Number: 6948975
• Product Code: KKX
• UDI-Device Identifier: 00618125140039
• UDI-Public: 00618125140039
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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
• Device Model Number: 5403
• Device Catalogue Number: 5403
• Device Lot Number: 034991
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown