MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; LAVAGE, JET

Catalog Number UNK_INS

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Discarded.

Event Description

It was reported by the customer that after the procedure and during disposal of the batteries, that the customer cut the wires on the battery and then noticed that one pack was smoldering and cackling in the bag.There was no patient involvement.

Manufacturer Narrative

Follow-up report submitted to document investigation results.

Event Description

It was reported by the customer that after the procedure and during disposal of the batteries, that the customer cut the wires on the battery and then noticed that one pack was smoldering and cackling in the bag.There was no patient involvement.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7748694
• MDR Text Key: 116049503
• Report Number: 0001811755-2018-01561
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• 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