MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. FORCEPS, WAVE SIDE GRASPER

Model Number 8383.2937

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

Risk manager reported to richard wolf medical instruments corporation (rwmic) that during a case, the device in question broke.Prior to completing procedure, before closing of patient, it was noted a portion of the device was missing.Device broke and a portion of the device fell into patient abdominal cavity.X-ray was performed and confirmed foreign object was in patient.Foreign object was out of the field of view of the surgeon and after exploration foreign object was not found.Surgeon made the decision to leave the foreign object in place rather than risk a continued search and possible injury.No complication reported from patient.

Manufacturer Narrative

Handle is manufactured by richard wolf medical instruments corporation (rwmic).It is then sent to endoplus where they manufacture and attach the sheath and forceps.Completed device is then returned to rwmic for distribution.Rwmic received device on 12/11/2014 and performed a visual evaluation of the device.Rwmic found the distal part of one of the connecting pieces between pullrod and jaw was broken of and was not present.It appears the material failed due to wear and tear.Device in question has been in use for some time as the id# was hard to read and the serial number had been completely worn off.A request for additional patient information as well as details on the event was submitted to facility on (b)(4) 2014.Facility responded on (b)(6) 2014 and report was updated accordingly.The device in question was given to endoplus representative on (b)(6) 2014 for further evaluation.Endoplus has indicated they will also submit an mdr report of their findings.Rwmic considers this matter closed.However, in the event rwmic receives additional information, outside of endoplus investigation results, rwmic will provide endoplus and fda with follow-up information.Facility has purchased fifteen similar devices in the last eight years with twelve of the devices being purchased over five years ago.A tot al of three devices have been sent in for repair, two in 2011 and one in 2012.No other devices have been sent in for repair or routine maintenance.

• Brand Name: FORCEPS, WAVE SIDE GRASPER
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy (rwmic); vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 4381391
• MDR Text Key: 5240627
• Report Number: 1418479-2014-00056
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8383.2937
• Device Catalogue Number: 8383-2937
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 YR
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR