MAUDE Adverse Event Report: RICHARD WOLF GMBH RICHARD WOLF STERILISATION BASKET FOR FLEXIBLE ENDOSCOPESB 4,6MM; STERILIZATION TRAY

Model Number 8584.1240

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

The initial product evaluation found that there were several sharp edges and one wire sticking out on the underneath of the basket.A questionnaire was filled out by the customer and returned to rw (b)(4).It was confirmed that there was no patient involvement and the incident occurred during assembly in mdrd.The product was sent to the supplier for further evaluation and repair.The supplier also confirmed the complaint.All sharp edges were removed and any sub-standard welds were corrected so that there is no more possibility to injure fingers when handling.The instructions for use (ifu) contains instructions to check the product before and after each use, and not use the product if it is damaged or incomplete: 7 use attention immediately before and after use, check the product for damage, loose parts and completeness.Do not use the product if it is damaged and/or incomplete or has loose parts.The potential for injury from damaged or incomplete products is also described in the ifu: 8 checks caution injury from damaged or incomplete products! injuries of the patient, user or others are possible.-carry out checks before and after each use.-do not use damaged or incomplete products.-return damaged products for repair.-do not attempt to do any repairs yourself.Run through the checks before and after each use.1.Check the reprocessing basket for: -damage -sharp edges -loose or missing parts.2.Check o-rings (3) for damage.-replace damaged o-rings (3).(see section 11 spare parts and accessories) 3.Any inscriptions or identification necessary for the safe intended use must be legible.-to prevent wrong handling, any illegible lettering, labeling or identification must be reinstated.The product was sent to the supplier for further evaluation and repair.The supplier also confirmed the complaint.All sharp edges were removed and any sub-standard welds were corrected so that there is no more possibility to injure fingers when handling.The original final inspection document at the supplier shows no problems in production.The root cause of the issue is ineffective final inspection.The complaints database was searched between 01/01/2016 to 02/07/2019 and in this period, there were (b)(4) basket sold, and the search returned one similar complaint with the richard wolf reference (b)(4) from a different batch.As corrective measures triggered by the complaint (b)(4), the supplier put in place an improved assembly and final inspection zone and tightened up the final inspections.These measures were implemented on 01/04/2019.The basket subject to the current complaint was produced on 11/02/2019, therefore before the corrective measures were implemented.Since implementation of the measures, there have been no further complaints reported regarding this issue.As a result, no further investigation or action is warranted for this case, and richard wolf gmbh considers this complaint as closed.

Event Description

On (b)(6) 2019, richard wolf (b)(4) (rw (b)(4)) received the following information: staff injury in the form of a cut from handling the wolf mesh sterilization container 85841240.The next day, the staff member responsible for shipping out this container for repair was cut by another area of the container.Also, of note, these are not the first of these injuries to occur since the purchase of these containers.

• Brand Name: RICHARD WOLF STERILISATION BASKET FOR FLEXIBLE ENDOSCOPESB 4,6MM
• Type of Device: STERILIZATION TRAY
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): PLASTIFILL SA; piazzale roncàa 2; mendrisio, 6850 ; SZ 6850
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10119107
• MDR Text Key: 195577004
• Report Number: 9611102-2019-00021
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8584.1240
• Device Catalogue Number: 8584.1240
• Device Lot Number: WSC 4500263833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other