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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE
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INVUITY, INC PHOTONBLADE Back to Search Results
Model Number PB1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The invuity areas sales manager (asm) followed up with the hospital and confirmed that the pacemaker lead was nicked and repaired using an intra-operative kit.No further information was available.
 
Event or Problem Description
Approximately (b)(6) 2018, during a pacemaker change out the insulation of a lead was accidentally damaged.A repair kit was used to fix the lead intraoperatively.The case was completed with no further incident and no impact to the patient.This incident was reported to invuity on (b)(4) 2018.
 
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Brand Name
PHOTONBLADE
Common Device Name
PHOTONBLADE
Manufacturer (Section D)
INVUITY, INC
444 de haro st
san francisco CA 94107
MDR Report Key7661760
Report Number3011394215-2018-00004
Device Sequence Number13968826
Product Code GEI
UDI-Device Identifier00816728020158
UDI-Public00816728020158
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K162053
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/05/2018
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 Physician
Device Model NumberPB1
Device Catalogue NumberPB1
Device Lot NumberUNKNOWN
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 06/05/2018
Initial Report FDA Received Date07/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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