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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN

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AESCULAP AG BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN Back to Search Results
Model Number JK341
Device Problem Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the components have been examined visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera. First we made a visual inspection of the container lid silver jk389 without the filter retention plate jk100. Here we found slight visible damage. Additionally we found cracks in the container gasket (b)(4). Next we made a visual inspection of the filter retention plate jk100. Here we found no failure. We made a visual inspection of the round polypropylene filter md344. Here we found no failure. Next we made a visual inspection of the bottom jk341. Here we found unknown deposits. Conclusion and root cause: the root cause of the problem is most probably reprocessing related. Rational: according to the quality standard, a material defect or production error can be excluded. We can not determine the exact cause but we exclude a product failure as the causal factor. We found no direct relation between the complaint and the deviation of the product. Additionally to the statement in sap: ". Some factors to consider are that the hospital has been going through a lot of construction/building, they have been having water problems, and they recently moved their whole sterilization process. The debris was found in wrapped sets and genesis containers. This was initially noticed when the sets were being opened in the operating room in ortho and neuro sets. ". Therefore there is the possibility of a reprocessing failure. There is the possibility that the damaged container gasket (b)(4) was caused by a sharp instrument or an improper handling. We assume that the slightly visible damage are traces of use. No capa is necessary.
 
Event Description
Country of complaint: usa. Additional information follow up: components in use listed as concomitant devices are: jk100 / filter retention plate, md344 / round filter polypropylene.
 
Manufacturer Narrative
Additional information follow up: all med watch submissions related to this report are: (b)(4).
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: usa. After the sterilization process was completed, a black debris was noticed in the bottom of the container. This has happened in several sets and we are trying to determine where the debris is coming from and what it is specifically. No injury to patient. No delay in surgery, but there were cancellation of surgery. Components in use listed as concomitant devices are: jk341 / bottom for 1/2 container height:120 mm. Jk389 / 1/2-size lid w/retention plate silver. Jf114r / 1/2 size perf basket 243 x 253 x 106 mm.
 
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Brand NameBOTTOM FOR 1/2 CONTAINER HEIGHT:120MM
Type of DeviceCONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7162299
MDR Text Key282260912
Report Number9610612-2018-00004
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK341
Device Catalogue NumberJK341
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/02/2018
Event Location No Information
Date Manufacturer Received01/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/03/2018 Patient Sequence Number: 1
Treatment
JF114R / 1/2 SIZE PERF BASKET 243X253X106MM; JK100 / FILTER RETENTION PLATE; JK341 / BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM; JK389 / 1/2-SIZE LID W/RETENTION PLATE SILVER; MD344 / ROUND FILTER POLYPROPYLENE
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