MAUDE Adverse Event Report: STERILMED, INC. LIGACLIP; CLIP, IMPLANTABLE, REPROCESSED

Model Number ETHMCL20

Device Problems Use of Device Problem (1670); Failure to Fire (2610)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

Patient with a history of comorbidities including of high blood pressure, diverticulitis and hypercholesterolemia, previous procedure endoscopic retrograde cholangiopancreatography and stone extraction from the common bile duct, was admitted for a laparoscopy and open cholecystectomy.During the procedure, the four mcl20 reprocessed multi clip applier opened and failed to fire.A total of four failed.A fifth clip was used and worked as expected.No known harm to patient.Pictures include all 4 devices.

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway n; suite 2; plymouth MN 55446
• MDR Report Key: 12851433
• MDR Text Key: 281079052
• Report Number: 12851433
• Device Sequence Number: 1
• Product Code: NMJ
• UDI-Device Identifier: 10888551019057
• UDI-Public: (01)10888551019057(17)211118(10)2142377
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETHMCL20
• Device Catalogue Number: ETHMCL20
• Device Lot Number: 2142377
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 108 KG