MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF1637

Device Problem Accessory Incompatible (1004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - incompatible software revision on generator.- ancillary equipment failure - not fully seating device into console during initial connection the instructions for use (ifu) state: reprocessed ligasure is compatible with: forcetriad sw (b)(4), vlft10gen sw (b)(4) note: devices with valleylab plug are not compatible with vlft10gen sw (b)(4) or higher.Before beginning the procedure, verify overall compatibility of all instruments and accessories.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

Event Description

It was reported the generator said the ligasure was incompatible during the procedure.They tied off vessel by hand because the device did not work.They did not replace the device.There was no patient injury reported and delay was 30 minutes to troubleshoot.These are commonly used devices that are readily available.

Event Description

It was reported the generator said the ligasure was incompatible during the procedure.They tied off vessel by hand because the device did not work.They did not replace the device.There was no patient injury reported and delay was 30 minutes to troubleshoot.These are commonly used devices that are readily available.

Manufacturer Narrative

On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 9379811
• MDR Text Key: 182559587
• Report Number: 0001056128-2019-00062
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00885825017620
• UDI-Public: 00885825017620
• Combination Product (y/n): N
• PMA/PMN Number: K133578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2020
• Device Model Number: LF1637
• Device Catalogue Number: LF1637RR
• Device Lot Number: 5731512
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention