* 20711070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-06 for * 20711070 manufactured by Karl Storz Endoscopy-america. Inc..

Event Text Entries

[18913770] The patient was undergoing a laparoscopic hysterectomy. The unit for the morcellator shut down and had to be changed. Then the gearshaft in the handpiece overheated and had to be replaced. During the procedure, the morcellator was sluggish. The surgeon was unable to complete the surgery using the morcellator, and had to use an alternative method which prolonged the case an hour and a half. It was noted that the caps and seals do not fit snugly on any of the handpieces. Additional follow-up reveals: follow-up with the manufacturer found a wrong display on the faceplate when they first turned on the unit (instead of flashing eo2, it showed 1000). Also there was no power to the motor control board. There was a blown fuse at f001 location on the motor control board. The fuse was replaced, and the unit worked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 660119
• MDR Report Key: 660119
• Date Received: 2005-12-06
• Date of Report: 2005-12-06
• Date of Event: 2005-11-18
• Report Date: 2005-12-06
• Date Reported to FDA: 2005-12-06
• Date Added to Maude: 2006-01-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: MORCELLATOR GEAR SHAFT
• Product Code: HFG
• Date Received: 2005-12-06
• Returned To Mfg: 2005-11-19
• Model Number: *
• Catalog Number: 20711070
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 649553
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA. INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: MORCELLATOR UNIT
• Product Code: HFG
• Date Received: 2005-12-06
• Returned To Mfg: 2005-11-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 649554
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICAL, INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2005-12-06