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

Catalog Number	550025S316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/31/2020
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 artery was cut resulting in a patient arterial bleed.It was also reported that the surgeon was able to recover and stabilize the bleed and the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the sonopet iq tip reported involved in this event was not returned for evaluation.As a result no further testing of the product involved was possible.Although the device was not available information provided relating to the event concluded that this adverse event is attributed to a use error where the surgeon believed that the device would not damage the pca(posterior cerebral artery) if they came in contact with the structure even while ultrasonic power was active.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 there was no malfunction reported with the product used.It was further reported that the patients artery was cut resulting in a patient arterial bleed.It was also reported that the surgeon was able to recover and stabilize the bleed and the procedure was completed successfully.

• Brand Name: 12CM IQ SERRATED LARGE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9950127
• Report Number: 0001811755-2020-00901
• Device Sequence Number: 11342829
• Product Code: LFL
• UDI-Device Identifier: 37613327422420
• UDI-Public: 37613327422420
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/15/2020

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: 550025S316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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