MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. CORDLESS GAMMA PROBE COVER

Model Number	GPC415
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr was reviewed for lot d161671 and it was noticed that this lot had 800 pieces that were manufactured from 06/16/16 to 06/18/16.No defects related to the non conformance were reported during quality inspection.At the time of this report, no 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
The end user is reporting: sterile probe cover used to cover unsterile probe during surgery.Post procedure when probe cover removed there was blood on the probe.On inspection blood seeped through seams and micro hole in cover.No visible hole present.The same thing happened in june.All probe covers of that lot number are pulled from service.

• Brand Name: CORDLESS GAMMA PROBE COVER
• Common Device Name: PROBE COVER
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; zona franca no. 2; la romana, ; DR
• MDR Report Key: 6804885
• Report Number: 8043817-2017-00021
• Device Sequence Number: 983981
• Product Code: KKX
• UDI-Device Identifier: 00748426076451
• UDI-Public: (01)00748426076451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: GPC415
• Device Lot Number: D161671
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1