MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG OBWEGESER RAMUSCLAMP, NARROW, RIGHT, 20CM; INSTRUMENT

Catalog Number 01-17994

Device Problem Break (1069)

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

Event Date 08/19/2014

Event Type  malfunction  

Event Description

It is reported by nurse of the hospital that she opened the packaging of the ramusclamp and observed that it is broken.A replacement was available to complete the surgery.

Manufacturer Narrative

Investigation in progress but not yet complete.

Manufacturer Narrative

The reported event could not be confirmed because the ramusclamp broke during application after unpackaging.The investigation result shows that the breakage was caused by too high bending forces during application/opening and closing the instrument.The device also shows residues and corrosion, which shows that the device has been used and the failure did not occur right after unpacking.Considering the technical investigation results there are no indications for any design, material or manufacturing related issue.

Event Description

It is reported by nurse of the hospital that she opened the packaging of the ramusclamp and observed that it is broken.A replacement was available to complete the surgery.

• Brand Name: OBWEGESER RAMUSCLAMP, NARROW, RIGHT, 20CM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: julie schoell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 4065007
• MDR Text Key: 4810132
• Report Number: 0008010177-2014-00244
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-17994
• Device Lot Number: 1000072028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• 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