MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. INTRAOPERATIVE PROBE COVER W/GEL

Model Number	PC1292
Medical Device Problem Codes	Hole In Material (1293); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, no lot number or sample had been provided.As no device was available for evaluation, the root cause of this complaint cannot be confirmed.If additional information becomes available, a follow up report will be submitted.
Event or Problem Description
End user reported a quality issue with the intraoperative probe cover pc1292.The probe cover was ripped/falling apart.The issue was not identified until after the cover had been passed to the field, requiring the staff to have to tear down their sterile field and set it all back up.

• Brand Name: INTRAOPERATIVE PROBE COVER W/GEL
• Common Device Name: PROBE COVER
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; zona franca no. 2; la romana, ; DR
• MDR Report Key: 6865280
• Report Number: 8043817-2017-00026
• Device Sequence Number: 801066
• Product Code: KKX
• UDI-Device Identifier: 50748426047869
• UDI-Public: (01)50748426047869
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: PC1292
• Device Lot Number: UNKNOWN
• 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: 08/16/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1