MAUDE Adverse Event Report: TELEFLEX INCORPORATED WECK; APPLIER, SURGICAL, CLIP

Model Number 137081

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2021

Event Type  malfunction  

Event Description

Parathyroidectomy procedure.Incision at 1022.At 1034, surgeon was using a "reusable" hemoclip applier small, when the device malfunctioned, causing the clip to bisect a vessel.With a new clip and suture tie, the vessel injury was quickly repaired.The doctor asked that the particular clip applier be removed from service, as she did not think it could be repaired for correct functioning.She asked if a disposable small clip applier was available, but that size is not part of our inventory.Another reusable small hemoclip applier was added to the sterile field, which the surgeon used without issues.Pod 3 leader and st gen surg resource brought to or room to discuss instrument issue with doctor.The instrument was labeled "request to be taken out of service" and sent to csr at end of procedure.

• Brand Name: WECK
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12680817
• MDR Text Key: 277923258
• Report Number: 12680817
• Device Sequence Number: 1
• Product Code: GDO
• 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: 10/15/2021

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: 137081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28105 DA