MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INRPLS HP W/COAX MULTI-ORIFICE; LAVAGE, JET

Catalog Number 0210158000

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Discarded.

Event Description

It was reported that during testing, the device would not shut off after being removed from the package and the battery pack handle became hot to the touch.There was no patient involvement as there was no associated procedure.Additionally, no adverse consequences were reported for the user.

• Brand Name: INRPLS HP W/COAX MULTI-ORIFICE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7461699
• MDR Text Key: 106702974
• Report Number: 0001811755-2018-00628
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 7613327351002
• UDI-Public: (01)7613327351002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210158000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1