MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ELECTROSURGICAL, CUTTING COAGULATION, LAPAROSCOPIC ENDOSCOPIC, REPROCESSED

Model Number LF1944

Device Problem Misfire (2532)

Patient Problem Failure to Anastomose (1028)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

Laparoscopic ligasure¿ maryland jaw device, reprocessed by stryker #1944, misfired and did not completely seal.

• Brand Name: N/A
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION, LAPAROSCOPIC ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 14418221
• MDR Text Key: 291927219
• Report Number: 14418221
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327504903
• UDI-Public: (01)07613327504903
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022,04/19/2022

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
• Device Operator: Health Professional
• Device Model Number: LF1944
• Device Catalogue Number: LF1944
• Device Lot Number: 13600477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Date Report to Manufacturer: 05/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Weight: 129 KG
• Patient Ethnicity: Hispanic
• Patient Race: White