MAUDE Adverse Event Report: AESCULAP AG AND CO. KG MINOP MICRO SCISSORS B/B 2/265MM; NEUROLOGICAL SCISSORS

Model Number FF386R

Device Problems Device Operates Differently Than Expected (2913); Inadequate User Interface (2958); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Client complained: small fragment of metal broke away from scissor whilst in ventricle of patient ((b)(6)).Fragment was immediately retrieved by neurosurgeon.Patient had a ct scan.No damage noted from incident that occurred in operating theatres.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: upon receipt, the instrument shows a plurality of damages.The rivet holding the scissor blades has slipped out.The distal end of the instrument, the inner and outer tubes are bent.The spring tabs of the outer tube are completely deformed.The investigation determined that the fragment that fell off is part of the slipped out rivet.The slipped out rivet and bent parts of the instrument are indicative of mechanical overload.The spring tabs were deformed by putting the outer tube over the inner tube in the wrong direction.The material or product deviations could not be verified.The failure has been determined to be user related.

• Brand Name: MINOP MICRO SCISSORS B/B 2/265MM
• Type of Device: NEUROLOGICAL SCISSORS
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen 7853 2; DA 78532
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047667
• MDR Text Key: 4810248
• Report Number: 2916714-2014-00626
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF386R
• Device Catalogue Number: FF386R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other