MAUDE Adverse Event Report: STERILMED, INC. 5MM MARYLAND JAW SEALER/DIVIDER, 37CM; ELECTROSURG, CUTTING/COAGULATION ACCESS, LAPAROSCOP/ENDOSCOP, REPROCESSED

Catalog Number COVLF1737

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no discrepancies observed.(b)(4).

Event Description

It was reported that a patient underwent a laparoscopically assisted vaginal hysterectomy procedure with a 5mm maryland jaw sealer/divider, 37cm and the surgeon advised the ligasure worked the first time properly, then felt that it was sticking and not cauterizing.The device did contact the patient and the tips were sticking to healthy tissue.There was no end tone or error tone from the device.Another refurbished maryland ligasure was used to complete the procedure and there was no patient consequence.The intent of the procedure was not altered as a result of this event.

Manufacturer Narrative

It was reported that a patient underwent a laparoscopically assisted vaginal hysterectomy procedure with a 5mm maryland jaw sealer/divider, 37cm and the surgeon advised the ligasure worked the first time properly, then felt that it was sticking and not cauterizing.The device was returned in an open box with very little protective material.None of the original packaging was returned.The account provided a box label for reference.The device history record for the lot was reviewed and no defects or issues related to the reprocessing procedures related to the device and complaint, were found during the review.The device was returned with biological contaminants in and around the jaws, along its handle and shaft.Given that it was reported that the tips were sticking to healthy tissue, it was expected to see more tissue or eschar stuck to the jaws, but the surfaces had minor contaminants.The device was examined and was attached to a multimeter to verify proper current flow, continuity and isolation.The device passed these examinations.It was then plugged into both our forcetriad & valleylab ft10 generators and the device was recognized by both platforms.There was a usage limit exceeded error displayed on the ft10 generator.This indicates the device had fully completed functional use, via its rfid tag, but there were no errors displayed on the forcetriad generator.The usage limit exceeded error on the ft10 is also indicative that the device had achieved the necessary end tones and that a seal would have been completed, further supported by the surgeon's statement that the device worked the first time properly.It's unclear how much time had passed between the device's usage.As the device was functional on the forcetriad generator, a test strip was placed in the jaw to evaluate the device's sealing capability.Heat and steam were observed during the actuation of the device and it completed the function testing, producing the necessary end tones indicating the end cycle had been properly achieved.The test showed the device capable of cauterizing and functioning as designed.There is no clear indication or verification that the tips of the device would stick to tissue.Unable to duplicate or verify the reported issue.As device was removed from its packaging and was handled, no conclusion could be made as to the cause of the reported issue.Manufacturer's ref.No: (b)(4).

• Brand Name: 5MM MARYLAND JAW SEALER/DIVIDER, 37CM
• Type of Device: ELECTROSURG, CUTTING/COAGULATION ACCESS, LAPAROSCOP/ENDOSCOP, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8259381
• MDR Text Key: 133521207
• Report Number: 2134070-2019-00118
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888551044462
• UDI-Public: 10888551044462
• Combination Product (y/n): N
• PMA/PMN Number: K143260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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 Expiration Date: 05/09/2019
• Device Catalogue Number: COVLF1737
• Device Lot Number: 2010707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1