MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 12CM IQ APEX 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
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 there was no malfunction reported with the product used.It was further reported that the patients required medical intervention to treat a cut caused by unintended activation of the product.It was also reported that a delay of 30 minutes occurred as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure there was no malfunction reported with the product used.It was further reported that the patients required medical intervention to treat a cut caused by unintended activation of the product.It was also reported that a delay of 30 minutes occurred as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 12CM IQ APEX 360
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11413222
• Report Number: 0001811755-2021-00723
• Device Sequence Number: 17235648
• Product Code: LFL
• UDI-Device Identifier: 37613327422413
• UDI-Public: 37613327422413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550025B312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR