| Date Initiated by Firm |
June 08, 2023 |
| Date Posted |
August 17, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2413-2023 |
| Recall Event ID |
92579 |
| 510(K)Number |
K152092 K102781 K120418 K100275
|
| Product Classification |
Electrode, electrosurgical, active, urological - Product Code FAS
|
| Product |
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.
64 Models:
1) A22201C
2) A22201D
3) A22202C
4) A22203C
5) A22205C
6) A22205D
7) A22206C
8) A22207C
9) A22211C
10) A22221C
11) A22222C
12) A22223C
13) A22231C
14) A22231D
15) A22251C
16) A22253C
17) A22255C
18) A22257C
19) A22258C
20) A22266C
21) A44728C
22) WA22037C
23) WA22038C
24) WA22039C
25) WA22301D
26) WA22301S
27) WA22302D
28) WA22305D
29) WA22305S
30) WA22306D
31) WA22332D
32) WA22351C
33) WA22355C
34) WA22503D
35) WA22507D
36) WA22521C
37) WA22523C
38) WA22537D
39) WA22538C
40) WA22539D
41) WA22540S
42) WA22541S
43) WA22542S
44) WA22544S
45) WA22557C
46) WA22566S
47) WA22602D
48) WA22603D
49) WA22606D
50) WA22607D
51) WA22621C
52) WA22623C
53) WA22632D
54) WA22651C
55) WA22655C
56) WA22657C
57) WA47505S
58) WA47506S
59) WA47507S
60) WA47540S
61) WA47551S
62) WA47555S
63) WA47560S
64) WA47566S |
| Code Information |
# Model UDI(DI)
1) A22201C 14042761036648
2) A22201D 14042761036655
3) A22202C 14042761036662
4) A22203C 14042761036686
5) A22205C 14042761036709
6) A22205D 14042761036716
7) A22206C 14042761036723
8) A22207C 14042761036747
9) A22211C 14042761036761
10) A22221C 14042761029466
11) A22222C 14042761030431
12) A22223C 14042761029770
13) A22231C 14042761036778
14) A22231D 14042761036785
15) A22251C 14042761036815
16) A22253C 14042761036822
17) A22255C 14042761036839
18) A22257C 14042761030448
19) A22258C 14042761036853
20) A22266C 14042761036891
21) A44728C 14042761039090
22) WA22037C 14042761051566
23) WA22038C 14042761051580
24) WA22039C 14042761051603
25) WA22301D 14042761051658
26) WA22301S 14042761082386
27) WA22302D 14042761051665
28) WA22305D 14042761051672
29) WA22305S 14042761082393
30) WA22306D 14042761051689
31) WA22332D 14042761051702
32) WA22351C 14042761051719
33) WA22355C 14042761051719
34) WA22503D 14042761068205
35) WA22507D 14042761068236
36) WA22521C 14042761068243
37) WA22523C 14042761068267
38) WA22537D 14042761073940
39) WA22538C 14042761073964
40) WA22539D 14042761073971
41) WA22540S 14042761083710
42) WA22541S 14042761083727
43) WA22542S 14042761083734
44) WA22544S 14042761083758
45) WA22557C 14042761068342
46) WA22566S 14042761083765
47) WA22602D 14042761075456
48) WA22603D 14042761075463
49) WA22606D 14042761075470
50) WA22607D 14042761075487
51) WA22621C 14042761075494
52) WA22623C 14042761075500
53) WA22632D 14042761075517
54) WA22651C 14042761075524
55) WA22655C 14042761075531
56) WA22657C 14042761075548
57) WA47505S 14042761085035
58) WA47506S 14042761085042
59) WA47507S 14042761085073
60) WA47540S 14042761085103
61) WA47551S 14042761085059
62) WA47555S 14042761085066
63) WA47560S 14042761085080
64) WA47566S 14042761085097
All lot numbers |
Recalling Firm/
Manufacturer |
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
|
| For Additional Information Contact |
same
484-896-5000
|
Manufacturer Reason
for Recall |
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
|
FDA Determined
Cause 2 |
Process design |
| Action |
Olympus issued URGENT: Medical Device Field Corrective Action letter Information on additional Caution in Instructions for Use (IFU) dated June 8, 2023.
Letter states reason for recall, health risk and action to take:
Carefully read the content of this Field Corrective Action letter.
2. Ensure that all personnel are completely knowledgeable and thoroughly trained on the content of this letter. In particular, observe the instructions of the additional Cautions:
Use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects. Do not activate the HF-resection electrode while any portion of the HF-resection electrode tip is in contact with another metal object. This can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip. If excessive heating or physical forces cause damage to the HF-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal. In some electrode models a second additional Caution has been added:
Contact between the HF-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the HF-resection electrode and the metal part. Always keep a distance of at least 10 mm between the HF-resection electrode and metal parts
3. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email (Olympus7544@sedgwick.com) or Fax (888-345-4628). For any questions about the acknowledgement form, please call the Sedgwick team at 888-843-0252.
If you have further distributed this product, identify your customers and forward them this letter. Please appropriately document your notification process and let us know the end-customer feedback accordingly.
If you have any questions or concerns, please do not hesitate to contact me directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com |
| Quantity in Commerce |
62704 boxes |
| Distribution |
US Nationwide distribution.
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = FAS and Original Applicant = OLYMPUS WINTER & IBE GMBH
|
