• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MACRO FORCEPS 5/420MM ENDOSCOPY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG JAW INS.BIP.MACRO FORCEPS 5/420MM ENDOSCOPY Back to Search Results
Model Number PM436R
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the components have been examined visually and microscopically with a keyence vhz-5000 digital microscope and a panasonic dmc tz8 digital camera. We made a visual inspection of the instrument. Here we found a bent pull rod pm434203. Furthermore we made a visual inspection of the jaw parts. Here we found a not laterally overlapping jaw. Additionally we found a visibly damaged grey ceramic with a broken off area and a broken grey ceramic. Conclusion and root cause: the root cause of the problem is most probably usage related. Rational: we assume a mechanical overload situation as the causal factor and these will result in the not overlapping jaw and ceramic breakages. There is the possibility of torsion or high leverage with the instrument. According to the quality standard a production error and a material defect can be excluded. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: usa. The surgeon reported that during use the tip of the insert jaw over heats during surgery. No harm to patient reported. No surgical delays reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJAW INS.BIP.MACRO FORCEPS 5/420MM
Type of DeviceENDOSCOPY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6653630
MDR Text Key246681509
Report Number9610612-2017-00327
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM436R
Device Catalogue NumberPM436R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/07/2017
Event Location No Information
Date Manufacturer Received06/01/2017
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 Initial

Patient Treatment Data
Date Received: 06/20/2017 Patient Sequence Number: 1
-
-