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

Model Number ETHMSM20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was unable to be reviewed as no lot number was obtained.

Event Description

It was reported that the patient was taken to surgery for bilateral removal of expanders.The surgeon was clipping intraoperatively and said the reprocessed clip applier tore the patient's blood vessel.The operative note states the patient lost 300 cc's.The patient required transfusion of one unit of packed red blood cells.Her surgery was completed and she was transferred to the recovery room in good condition.Additional information has been requested, but no response has yet been received.

• Brand Name: NA
• Type of Device: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth
• Manufacturer Contact: jay anderson ; 5010 cheshire parkway; ste 2; plymouth, MN
• MDR Report Key: 6986903
• MDR Text Key: 90545821
• Report Number: 2134070-2017-00074
• Device Sequence Number: 1
• Product Code: NMJ
• Combination Product (y/n): N
• PMA/PMN Number: K033579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ETHMSM20
• Device Catalogue Number: ETHMSM20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1