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

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

(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.

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).

• Brand Name: BOTTOM FOR 1/2 CONTAINER HEIGHT:120MM
• Type of Device: CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7162299
• MDR Text Key: 96456211
• Report Number: 9610612-2018-00004
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK341
• Device Catalogue Number: JK341
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/02/2018
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/16/2018; 01/16/2018
• Supplement Dates FDA Received: 01/29/2018; 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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
• Patient Outcome(s): Other