MAUDE Adverse Event Report: AESCULAP AG BOTTOM PERFOR.F.DENTAL CONTAINER JN096; STERILIZATION CONTAINERS

Model Number JN090

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: pendng further information.

Event Description

It was reported by the healthcare professional to the company sales representative "container lid and bottom is showing rust." no patient injury.60 minute delay in surgery.No additional intervention required.All med watch submissions related to this report are: 9610612-2018-00392(this report), 9610612-2018-00393.Components in use listed as concomitant devices are: jn090 / bottom perfor.F.Dental container jn096; jf264r / 1/4-size perf bskt w/lid 273x176x41mm; md895 / quarter-size instrument pad; jf264r / 1/4-size perf bskt w/lid 273x176x41mm.

Manufacturer Narrative

Investigation: (received 10/1/2018) the components have been examined visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the containers and found corrosion.Additionally we found dents and deformations.Conclusion and root cause: the root cause of the problem is most probably reprocessing related.Rationale: according to the quality standard, a material defect or production error can be excluded.We assume that the corrosions are a mix of pitting and surface corrosion.Investigations lead to the assumption that the corrosions were caused by a reprocessing failure.The pinprick-like corrosion holes, surrounded by sparkling , reddish-brown or multicolored corrosion spots, often associated with circular corrosion deposits around to corrosion hole.The following points could be the cause of this: exposure to halide ions (bromides, iodides and chlorides) but especially chlorides that locally break through the passive layer of instrument steel thus causing pitting.Dried on organic residues, eg.Blood, pus, secretions.Frequent pitting is due to the use of liquids with high chloride content, or more specifically due to dry residues of such liquids adhering to the instrument surfaces, eg.If the concentration of chlorides in the final rinse water is too high of if residues of physiological salt solutions remain on the instrument.Brand new instruments are particularly susceptible to attack by media containing chlorides due to their still thin passive layer.Instruments that have been used for some time are more resistant to chloride attack because they have developed a thicker passive layer.There is also the possibility that the pitting was caused due to etching effect.This could have been caused due to effects of acid due to over dosing of neutralizing chemicals or due to using acid-based cleaners.The surface corrosion could be caused by the following points: -chemical and electrochemical influences only in connection with an excessive acid content in case of stainless steel -long-term impact of water/condensate in the case of stainless steel.Furthermore the investigation lead to the assumption that the dents and deformations wer caused by an improper handling.This could have been caused due to storage or handling of the containers, or due to a vacuum damage.Due to the functional test we have determined that they are not equal to the specifications.The devices should not have been used with the described damages.No capa is necessary.Corrected data: added additional detail about how issue was discovered.

Event Description

No patient involvement.Issue was discovered while turning over sets for next upcoming case.

• Brand Name: BOTTOM PERFOR.F.DENTAL CONTAINER JN096
• Type of Device: STERILIZATION CONTAINERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7835259
• MDR Text Key: 118876940
• Report Number: 9610612-2018-00392
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• PMA/PMN Number: K792558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JN090
• Device Catalogue Number: JN090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Distributor Facility Aware Date: 08/15/2018
• Device Age: 3 MO
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JF264R / 1/4-SIZE PERF BSKT W/LID 273X176X41MM; JF264R / 1/4-SIZE PERF BSKT W/LID 273X176X41MM; JN090 / BOTTOM PERFOR.F.DENTAL CONTAINER JN096; MD895 / QUARTER-SIZE INSTRUMENT PAD