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

Model Number	GPC396
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples or pictures were received for this investigation.The dhr was reviewed for lot d171451 and it was confirmed that this lot had (b)(4) units that were manufactured on 05/25/2017.It was also confirmed that no defects were reported during the quality inspections.The training records were reviewed and it was confirmed that the operators involved in the manufacture of this lot were properly trained in the work instruction rev that was released when the affected lot was manufactured.On (b)(6) 2018 received a notification from the customer confirming the probe transducer was creating holes in the covers because of the sharp point.No actions are being taken at this time since the non-conformance is not related to the manufacturing process.The customer confirmed that the product was affected by their probe transducer.This is report 3 of 3.
Event or Problem Description
Medwatch report was received on (b)(6) 2018 with the following information: over the past week or so, the or noticed 4 surgical probe covers that have pin holes.4 drapes were saved, 3 patient information available (4th drape came with no patient information).Lot numbers on 2 cases can be confirmed as same and the 3rd has a different lot number.Reference numbers same on three (a fourth drape does not have any manufacturer/device information).This device was noted to have blood seepage into probe - it is believed that the probe touched patient's skin due to small size of hole.2 of the cases were sentinel nodes being retrieved and pin holes noted in probe cover when checked with saline after the case.A third case was a breast biopsy.No case delays.No patient harms noted to this point.Or team keeping an eye on any more probe covers with similar issues.Integrity of sterility is or team's concern.

• Brand Name: 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: 7452116
• Report Number: 8043817-2018-00012
• Device Sequence Number: 16384392
• Product Code: KKX
• UDI-Device Identifier: 00748426073337
• UDI-Public: (01)00748426073337
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: GPC396
• Device Lot Number: D171451
• 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: 03/28/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 66