MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 12CM IQ STANDARD; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025S307
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure the scrub tech held the tip of the device while it was activated which resulted in the tip burning through the scrub techs glove and burn to the tip of a finger.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure the scrub tech held the tip of the device while it was activated which resulted in the tip burning through the scrub techs glove and burn to the tip of a finger.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed.

• Brand Name: 12CM IQ STANDARD
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11285584
• Report Number: 0001811755-2021-00488
• Device Sequence Number: 3721338
• Product Code: LFL
• UDI-Device Identifier: 37613327422468
• UDI-Public: 37613327422468
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Catalogue Number: 550025S307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1