MAUDE Adverse Event Report: MEDGYN PRODUCTS INC BIERER OVUM FORCEPS; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Problem Device Issue (2379)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Medwatch report sent to us reporting that bierer forceps had malfunctioned and jammed on some tissue.This was removed carefully and without any trauma to the surrounding tissues.The procedure was then completed.An investigation was performed.We have been unable to confirm the bierer forceps description, item number or if it was instrument purchased from medgyn products.We have been unable to obtain the physical instrument named in this complaint.Without this, no failure or supporting root cause analysis can be determined as the nature of the complaint is isolated.It cannot be conclusively investigated without physical review of the bierer forceps and further customer clarification as to the nature of the "malfunction" and its corresponding patient impact.This issue will be continued to be monitored as more information is obtained.No corrective action will be issued at this stage.Our investigation reveals that there is no indication of an intermittent or systemic manufacturing defect with the instruments sold to (b)(4) in 2012.In sufficient evidence is available to determine if any of these instruments were apart of this complaint or if the subject instrument was actually purchased from medgyn.

• Brand Name: BIERER OVUM FORCEPS
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): MEDGYN PRODUCTS INC; 100w, industrial road; addison IL 60101
• Manufacturer Contact: shivashankar ; 100w, industrial road; addison, IL 60101 ; 6306274105
• MDR Report Key: 4963816
• MDR Text Key: 18290279
• Report Number: 1450908-2015-00001
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/01/2015,05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2015
• Event Location: Hospital
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR