MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO; INSTRUMENT, BIOPSY

Model Number 989603205282

Device Problems Difficult to Open or Close (2921); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

Biopsy gun would not close and set itself to take a sample.A different biopsy gun had to be opened to complete the procedure.Product did not have patient contact or patient harm.Manufacturer response for invivo biopsy gun, (brand not provided) (per site reporter): per vendor's request, we discarded the failed product and replacement will be sent.

• Brand Name: INVIVO
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• MDR Report Key: 11920102
• MDR Text Key: 253757546
• Report Number: 11920102
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989603205282
• Device Catalogue Number: 989603205282
• Device Lot Number: 1165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1