MAUDE Adverse Event Report: STERILMED, INC.; FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED

Model Number MIC1333

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

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 not reviewed as no lot number was given.

Event Description

It was reported that the device broke mid-procedure of a gi case while in the patient.No patient harm or consequences resulted in this.Additional details were given as follows: the jaw was retrieved and there was no damage to the patient.The wire was sticking out of the jaw.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.During the evaluation, the drive wire with a u-joint connector was found to be bent out of its position.A review of the device history record found that the device passed all visual and functional criteria prior to being shipped to the account.As the device was used during the procedure, no definitive cause for the reported observation could be determined.Per the instructions for use, the product is to be inspected for signs of damage or sterility compromise prior to use.As the device was inserted into the colonoscope, it is assumed there was no observed damage or bent wiring prior to insertion.As noted in the instructions for use, if excessive pressure was applied during advancement into the tissue or during handle manipulation, this could ¿cause jaw damage¿.A bent or constricted drive wire on the device may have been caused by forceful insertion of the instrument and/or caused by over-angulation of the endoscope during the procedure.

• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 6520710
• MDR Text Key: 73667238
• Report Number: 2134070-2017-00007
• Device Sequence Number: 1
• Product Code: NON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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: MIC1333
• Device Catalogue Number: MIC1333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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