MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; SCALPEL, ULTRASONIC, REPROCESSED

Model Number N/A

Device Problems Use of Device Problem (1670); Defective Component (2292); Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2019

Event Type  malfunction  

Event Description

Patient 1 of 3: during a lap paraesophageal hernia repair, the harmonic shears read "disconnect & reconnect" several times: screen said "replace" harmonic handpiece was not working.When scrub tech connected it to the cord and attempted to ready the system, the screen said replace instrument.Scrub tech did disconnect and re-connect several times, trying to ready the system.When that was not working, we replaced the handpiece with another one and the system worked fine.Patient 2 of 3: harmonic handpiece jaws used in laparoscopic roux-en-y with dr.Would not spring release like designed; new handpiece opened to field and malfunctioning handpiece was removed from field.Patient 3 of 3: error message displayed on harmonic machine.Followed prompts unplugged and plugged in cord, cleaned and tightened assembly.Unable to "clear" error.New disposable hand piece opened and new one functioned appropriately.Malfunctioning hand piece set aside.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8965094
• MDR Text Key: 156631071
• Report Number: 8965094
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: (01)07613327346251
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HARH36
• Device Lot Number: 9983441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 66