MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET

Catalog Number	0210200000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device had debris in sterile package.1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device did not have a root cause established.
Event or Problem Description
This report summarizes 1 malfunction event in which the device had debris in sterile package.1 event had patient involvement; no patient impact.

• Brand Name: INTERPULSE IRRIGATION ONLY HANDPIECE
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• MDR Report Key: 9244997
• Report Number: 0001811755-2019-03412
• Device Sequence Number: 1853784
• Product Code: FQH
• UDI-Device Identifier: 34546540144264
• UDI-Public: 34546540144264
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: No Information
• Device Catalogue Number: 0210200000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1